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BOSTON  PUBLIC  LIBRARY 


3  9999  66427_023_2_^ 

QUALITY  OF  HEALTH  CARE— HUMAN 
EXPERIMENTATION,  1973 


HEARINGS 

BEFORE   THE 

SUBCOMMITTEE  ON  HEALTH 

OF  THE 

COMMITTEE  ON 

LABOR  AND  PUBLIC  WELFARE 

UNITED  STATES  SENATE 

NINETY-THIRD  CONGRESS 

FIRST  SESSION 
ON 

S.  974 

To  amend  the  Public  Health  Service  Act  to  provide,  in  the  training  of 
health  professionals,  for  an  increased  emphasis  on  the  ethical,  social, 
legal,  and  moral  implications  of  advances  in  biomedical  research  and 

technology 

S.  878 

To  amend  the  Public  Health  Service  Act  to  provide  for  restrictions  on 

funds  for  experimental  use 

S.J.  Res.  71 

To  provide  for  a  study  and  evaluation  of  the  ethical,  social,  and  legal 
implications  of  advances  in  biomedical  research  and  technology 


MARCH  7  AND  8,  1973 


PART  3 


Printed  for  the  use  of  the  Committee  on  Labor  and  Public  Welfare 


QUALITY  OF  HEALTH  CARE— HUMAN 
EXPERIMENTATION,  1973 

HEARINGS 

BEFORE   THE 

SUBCOMMITTEE  ON  HEALTH 

OF  THE 

COMMITTEE  ON 

LABOR  AND  PUBLIC  WELFARE 

UNITED  STATES  SENATE 

NINETY-THIKD  CONGKESS 

FIRST  SESSION 
ON 

S.  974 
To  amend  the  Public  Health  Service  Act  to  provide,  in  the  training  of 
health  professionals,  for  an  increased  emphasis  on  the  ethical,  social, 
legal,  and  moral  implications  of  advances  in  biomedical  research  and 

technology 

S.  878 
To  amend  the  Public  Health  Service  Act  to  provide  for  restrictions  on 

funds  for  experimental  use 

S.J.  Res.  71 

To  provide  for  a  study  and  evaluation  of  the  ethical,  social,  and  legal 

implications  of  advances  in  biomedical  research  and  technology 


MARCH  7  AND  8,  1973 


PART  3 


Printed  for  the  use  of  the  Committee  on  Labor  and  Public  Welfare 

U.S.  GOVERNMENT  PRINTING  OFFICE 
93-999  0  WASHINGTON   :    1973 


For  sale  by  the  Superintendent  of  Documents, 

U.S.  Government  Printing  Office,  Washington  D.C.  20402 

Price:  $2.35  domestic  postpaid  or  $2  GPO  Bookstore 


COMMITTEE  ON  LABOR  AND  PUBLIC  WELFARE 

HARRISON  A.  WILLIAMS,  JR.,   New  Jersey,   Chairman 

JENNINGS  RANDOLPH,  West  Virginia  JACOB  K.  JAVITS,  New  York 

CLAIBORNE  PELL,  Rhode  Island  PETER  H.  DOMINICK,  Colorado 

EDWARD  M.  KENNEDY,  Massachusetts  RICHARD  S.  SCHWEIKER.  Pennsylvania 

GAYLORD  NELSON,  Wisconsin  ROBERT  TAFT.  Jr..  Ohio 

WALTER  F.  MONDALE,  Minnesota  J.  GLENN  BEALL,  Jr.,  Maryland 

THOMAS  F.  EAGLETON,  Missouri  ROBERT  T.  STAFFORD,  Vermont 

ALAN  CRANSTON,  California 
HAROLD  E.  HUGHES,  Iowa 
WILLIAM  D.  HATHAWAY,  Maine 

Stewart  E.   McClure.   Chief  Clerk 

Robert  E.   Nagle,   General  Counsel 

Roy  H.   MiLLENSON,  Minority   Chief  Clerk 

Eugene  Mittelman,  Minority  Counsel 


Subcommittee  on  Health 

EDWARD  M.   KENNEDY,   Massachusetts,   Chairman 

HARRISON  A.  WILLIAMS,  JR.,  New  Jersey     RICHARD  S.  SCHWEIKER,  Pennsylvania 

GAYLORD  NELSON,  Wisconsin  JACOB  K.  JAVITS,  New  York 

THOMAS  F.  EAGLETON,  Missouri  PETER  H.  DOMINICK,  Colorado 

ALAN  CRANSTON,  California  J.  GLENN  BEALL,  Jr.,  Maryland 

HAROLD  E.  HUGHES,  Iowa  ROBERT  TAFT,  Jr..  Ohio 
CLAIBORNE  PELL,  Rhode  Island 
WALTER  F.  MONDALE,  Minnesota 

LeRoy  G.  Goldman,  Professional  Staff  Member 
Jay  B.  Cctler,  Minority  Counsel 

(II) 


CONTENTS 


CHRONOLOGICAL  LIST  OF  WITNESSES 

\ 

Wednesday,   March  7,  1973 

Page 

Mitford,  Jessica,  author 794 

Cowan,  Geoffrey,  and  Aileen  Adams,  communications  law  program,  UCLA 

School  of  Law,  Los  Angeles,  Calif 797 

Wolfe,  Sidney  M.,  M.D.,  Health  Research  Group,  Washington,  D.C 809 

Sencer,  David  J.,  M.D.,  Acting  Administrator,  Health  Services  and  Mental 
Administration,  accompanied  by  John  Jennings,  M.D.,  Associate  Commis- 
sioner for  Medical  Affairs,  Food  and  Drug  Administration  ;  Peter  Barton 
Hutt,  Assistant  General  Counsel  for  Food  and  Drugs,  Department  of 
Health,  Education,  and  Welfare ;  David  M.  Link,  Director  of  the  Office 
of  Medical  Affairs,  Food  and  Drug  Administration ;  John  Zapp,  Deputy 
Assistant  Secretary  for  Legislation  (Health),  Department  of  Health, 
Education,  and  Welfare 814 

Jennings,  John,  M.D.,  Associate  Commissioner  for  Medical  Affairs,  Food 
and  Drug  Administration,  Public  Health  Service,  Department  of  Health, 
Education,  and  Welfare 815 

Lawson,  Allan  H.,  Prisoners'  Rights  Council,  Inc.,  Philadelphia,  Pa.,  accom- 
panied by  Charles  J.  Schoefer,  Philadelphia  People  Bail  Fund,  Philadel- 
phia, Pa.,  and  Leodus  Jones,  Community  Assistance  for  Prisoners,  Phil- 
adelphia, Pa 822 

Diamond,  Bernard  L.,  M.D.,  School  of  Criminology,  University  of  Cali- 
fornia        836 

Capron,  Alexander  Morgan,  M.D.,  assistant  professor  of  law.  University  of 
Pennsylvania  Law  School,  Philadelphia,  Pa 843 

Stetler,  C.  Joseph,  president.  Pharmaceutical  Manufacturers  Association, 
Washington,  D.C,  accompanied  by  John  G.  Adams,  Ph.  D.,  PMA  vice 
president  for  scientific  and  professional  relations,  and  Bruce  J.  Brennan, 
PMA  vice  president  and  general  counsel 864 

Thursday,   March   8,   1973 

Ervin,  Hon.  Sam  J.,  Jr.,  a  U.S.  Senator  from  the  State  of  North  Carolina 1026 

Gray,  Fred,  attorney  and  legislator,  State  of  Alabama,  accompanied  by 

Lester  Scott  and  Charles  Pollard 1033 

Barber,  Prof.  Bernard,  chairman,  Department  of  Sociology,  Barbard  Col- 
lege, Columbia  University 1043 

Katz,  Jay,  M.D.,  Yale  University  School  of  Law 1049 

Beecher,  Henry  K.,  M.D.,  Harvard  Medical  School,  Boston,  Mass 1059 

Barclay,  William  R.,  M.D.,  assistant  executive  vice  president,  American 
Medical  Association,  accompanied  by  Edwin  J.  Holman,  staff.  Legal  De- 
partment, American  Medical  Association 1067 

STATEMENTS 

Barber,  Prof.  Bernard,  chairman.  Department  of  Sociology,  Barbard  Col- 
lege, Columbia  University 1043 

Barclay,  William  R.,  M.D.,  assistant  executive  vice  president,  American 
Medical  Association,  accompanied  by  Edwin  J.  Holman,  staff,  Legal  De- 
partment, American  Medical  Association 1067 

Beecher,  Henry  K.,  M.D.,  Harvard  Medical  School,  Boston,  Mass 1059 

Capron,  Alexander  Morgan,  M.D.,  assistant  professor  of  law.  University  of 

Pennsylvania  Law  School,  Philadelphia,  Pa 843 

Prepared   statement 852 

(III) 


IV 

Cowan,  Geoffrey,  and  Aileen  Adams,  communications  law  program,  UCLA     Page 
School  of  Law,  Los  Angeles,  Calif _ 797 

Diamond,  Bernard  L.,  M.D.,  School  of  Criminology,  University  of  Cali- 
fornia       836 

Ervin,  Hon,  Sam  J.,  Jr.,  a  U.S.  Senator  from  the  State  of  North  Carolina..     1026 
Gray,  Fred,  attorney  and  legislator,  State  of  Alabama,  accompanied  by 

Lester  Scott  and  Charles  Pollard 1033 

Jennings,  John,  M.D.,  Associate  Commissioner  for  Medical  Affairs,  Food 
and  Drug  Administration,  Public  Health  Service,  Department  of  Health, 

Education,  and  Welfare 815 

Prepared  statement 818 

Katz,  Jay,  M.D.,  Yale  University  School  of  Law 1049 

Lawson,  Allan  H.,  Prisoners'  Rights  "^ouncil.  Inc.,  Philadelphia,  Pa.,  ac- 
companied by  Charles  J.  Schoefer,  Philadelphia  People  Bail  Fund, 
Philadelphia,  Pa.,  and  Leodus  Jones,  Community  Assistance  for  Pris- 
oners, Philadelphia,  Pa 822 

Prepared    statement 828 

Mitford,  Jessica,  author 794 

Sencer,  David  J.,  M.D.,  Acting  Administrator,  Health  Services  and  Mental 
Administration,  accompanied  by  John  Jennings,  M.D.,  Associate  Com- 
missioner for  Medical  Affairs,  Food  and  Drug  Administration ;  Peter 
Barton  Hutt,  Assistant  General  Counsel  for  Food  and  Drugs,  Department 
of  Health,  Education,  and  Welfare ;  David  M.  Link,  Director  of  the  Of- 
fice of  Medical  Affairs,  Food  and  Drug  Administration ;  John  Zapp, 
Deputy  Assistant  Secretary  for  Legislation   (Health),  Department  of 

Health,  Education,  and  Welfare 814 

Stetler,  C.  Joseph,  president.  Pharmaceutical  Manufacturers  Association, 
Washington,  D.C.,  accompanied  by  John  G.  Adams,  Ph.  D.,  PMA  vice 
president  for  scientific  and  professional  relations,  and  Bruce  J.  Brennan, 

PMA  vice  president  and  general  counsel 864 

Wolfe,  Sidney  M.,  M.D.,  Health  Research  Group,  Washington,  D.C 809 


ADDITIONAL  INFORMATION 

Articles,  publications,  etc. : 

"Florida  Prisoners  Assist  in  Testing  of  New  Drugs,"  by  Tom  Raum, 

from  the  Tallahassee  Democrat,  December  25,  1972 874 

"Money  Said  Main  Reason  Prisoners  Join  Drug  Tests,"  by  Tom  Raum, 

from  the  Clearwater  Sun,  December  25,  1972 876 

"Prison  Drug  Tests  Benefit  Supervisors,"  by  Tom  Raum,  from  the  Tal- 
lahassee Democrat,  December  24,  1972 872 

"Probe  Is  Ordered  of  Private  Payment  in  Prison  Drug  Tests,"  by  Tom 

Raum,  from  the  Tallahassee  Democrat.  December  28,  1972 873 

"The  Human  Guinea  Pig :  How  We  Test  New  Drugs,"  by  Aileen  Adams 

and  Geoffrey  Cowan,  published  in  World,  December  1972 798 

Communications  to : 

Capron,  Alexander  M.,  assistant  professor  of  law.  University  of  Penn- 
sylvania, Philadelphia.  Pa.,  March  12,  1973 861 

Kennedy,  Hon.  Edward  M.,  a  U,S.  Senator  from  the  State  of  Massachu- 
setts, from : 

Barclay,   William  R.,   M.D.,   assistant  executive  vice  president, 
American  Medical  Association,  Chicago,  111.  (with  enclosure) _.     1084 
Miscellaneous : 

Statements  and  pertinent  material  submitted  later  for  inclusion  in  the 
record  following  the  hearing  of : 

March  7,  1973 884-1022 

March  8,  1973 1084-1185 


QUALITY  OF  HEALTH  CARE— HUMAN 
EXPERIMENTATION.  1973 


WEDNESDAY,   MARCH  7,    1973 

U.S.  Senate, 
Subcommittee  on  Health  of  the 
Committee  on  Labor  and  Public  Welfare, 

Washington,  D.O. 

The  subcommittee  met  at  9 :30  o'clock  a.m.,  pursuant  to  call,  in  room 
6226,  New  Senate  Office  Building,  Senator  Edward  M.  Kennedy  (chair- 
man of  the  subcommittee)  presiding. 

Present :  Senators  Kennedy,  Pell,  and  Javits. 

Committee  staff  members  present :  LeRoy  G.  Goldman,  professional 
staff  member  and  Jay  B.  Cutler,  minority  counsel. 

Senator  Kennedy.  The  subcommittee  will  come  to  order. 

Today's  hearings  will  focus  primarily  on  the  use  of  prisoners  as 
subjects  of  medical  research. 

All  Americans  have  been  touched  by  and  have  profited  from  the 
products  of  biomedical  research.  And  yet  the  burden  of  developing 
those  products  is  not  equally  shared.  When  a  new  drug  is  tried  on  the 
first  human  being,  or  a  new  procedure  is  performed  for  the  first  time, 
there  is  a  considerable  risk  involved.  In  our  society  that  risk  is  taken 
most  often  by  the  poor,  the  minority  groups  and  the  institutionalized. 
Often  they  are  not  even  aware  of  those  risks. 

Often,  as  in  the  case  with  research  on  prisoners,  that  risk  is  taken 
in  order  to  escape  from  intolerable  living  conditions.  We  will  thor- 
oughly explore  these  issues  this  morning. 

During  these  hearings  we  have  repeatedly  seen  that,  in  the  absence 
of  quality  controls,  human  experimentation  can  become  part  of  the 
daily  practice  of  medicine.  We  will  begin  today  by  focusing  on  a  par- 
ticularly outrageous  abuse  that  occurred  in  Philadelphia  last  May. 
As  this  story  unfolds  we  should  ask  ourselves  whether  this  incident 
could  have  occurred  in  a  properly  regulated  medical  care  system  which 
was  oriented  to  the  protection  of  the  patients'  health  and  safety. 

Our  first  witness  this  morning  is  Dr.  Sidney  Wolfe  of  the  Health 
Research  Group  in  Washington,  D.C.  It  is  a  privilege  to  hear  from 
Dr.  Wolfe  on  the  use  of  DES,  among  other  things. 

Is  Dr.  Wolfe  here? 

(No  response.) 

Dr.  Sencer,  since  your  testimony  was  related  to  Dr.  Wolfe's,  we  will 
hold  that  for  a  brief  time  and  we  will  go  to  our  panel  of  witnesses, 
Jessica  Mitford,  Aileen  Adams,  and  Geoffrey  Cowman. 

Miss  Mitford  is  well  known  to  us,  and  has  made  a  recent  contribution 
to  the  field  in  the  form  of  an  article  entitled,  "Experiments  Behind 
Bars." 

(793) 


794 

Mrs.  Cowan  is  a  third-year  law  student  who  is  presently  working  as 
a  student  intern  at  the  Los  Angeles  Regional  Office  of  the  Federal 
Trade  Commission. 

Her  husband,  Geoffrey  Cowan,  is  an  adjunct  professor  at  the  UCLA 
at  Berkeley  Law  School  and  serves  as  a  member  of  the  UCLA  commit- 
tee which  examines  all  experimentation  on  human  beings. 

Miss  Mitf  ord,  would  you  care  to  start  us  off  ? 

STATEMENT  OF  JESSICA  MITFORD,  AUTHOR 

Miss  MiTFORD.  Thank  you  very  much.  Senator  Kennedy.  I  go  into 
this  subject  because  of  a  book  I  am  writing.  I  really  stumbled  on  the 
medical  experimentation  part  almost  by  chance. 

My  findings  are,  of  necessity,  only  a  tiny  beginning,  a  lifting  of  one 
corner  of  the  rug.  I  earnestly  hope  that  this  committee,  and  State  leg- 
islatures, physicians'  groups,  lawyers,  newspapers,  with  far  greater 
resources  than  I,  will  take  up  where  I  left  off. 

I  should  like  to  comment  on  these  aspects  of  drug  research  in 
prisons:  (1)  the  financial  exploitation  of  prisoners,  (2)  the  secrecy  and 
lack  of  safeguards,  (3)  the  danger  of  some  of  the  experiments,  and  (4) 
the  dereliction  of  Government  agencies  in  failing  to  provide  any  pro- 
tection to  the  prisoner-subjects. 

From  my  conversations  with  drug  company  executives  and  ])hysi- 
cians  involved  in  research,  I  learned  that  prisons  today  furnish  vir- 
tually the  entire  pool  of  human  subjects  of  phase  1  testing,  in  which 
the  new  compound  is  tried  out  for  possible  toxic  properties  on  a  small 
group  of  normal,  healthy  individuals. 

One  researcher  told  me,  "If  the  prisons  were  closed  down  tomorrow, 
the  pharmacuetical  companies  would  be  in  one  hell  of  a  bind." 

There  is  something  for  everybody  in  the  prison  research  studies.  The 
drug  companies,  operating  through  private  physicians  with  access 
to  the  prisons,  can  buy  human  subjects  for  a  fraction  less  than  one-tenth 
of  what  they  would  have  to  pay  students  or  other  free- world  volunteers. 

They  can  conduct  experiments  on  prisoners  that  would  not  be  sanc- 
tioned for  student-subjects  at  any  price  because  of  the  degree  of  risk 
and  pain  involved.  Guidelines  for  human  experimentation  established 
by  HEW  and  other  agencies  are  disregarded  behind  prison  walls. 

Since  the  studies  are  carried  out  in  the  secrecy  of  prison  if  a  "vol- 
unteer'' becomes  seriously  ill,  or  dies,  as  a  result  of  the  procedures 
to  which  he  is  subjected  it  is  unlikely  that  this  will  ever  come  to 
anybody's  attention.  There  is  minimal  risk  that  subjects  disabled  by 
the  experiments  will  bring  lawsuits  against  the  drug  companies,  for 
the  prisoner  is  usually  required  to  sign  a  waiver  releasing  everyone 
in  sight  from  damage  claims. 

Such  waivers  are  fraudulent,  worthless,  and  illegal.  They  have  been 
held  legally  invalid  as  contrary  to  public  policy,  and  are  prohibited 
by  FDA  regulations  having  the  force  of  law,  but  the  prisoner  is 
hardly  likely  to  be  aware  of  this. 

Senator  Kennedy.  How  often  did  you  find  the  use  of  waivers? 

Miss  MiTFORD.  At  least  three  or  four  occasions,  one  in  the  Maryland 
House  of  Corrections,  where  the  physician  in  charge  of  the  experi- 
ments. Dr.  Holneck,  sent  me  a  letter.  He  said  they  were  infecting 
healthy  men  there  with  typhoid  and  other  diseases. 


795 

He  sent  me  a  copy  of  the  waiver  which,  I  think,  I  have  used  the 
lan^age  of  in  my  article  in  the  Atlantic  Monthly  in  January.  Also, 
in  the  experiments  at  Vacaville,  in  California,  they  use  this  waiver. 

For  the  prisoner,  the  pittance  he  gets  from  the  drug  company — 
generally  around  $1  a  day  for  the  more  onerous  experiments — rep- 
resents riches  when  viewed  in  t^rms  of  prison  pay  scales:  $30  a 
month  compared  with  $2  to  $10  he  might  make  in  an  ordinary  prison 

The  participating  physician  cashes  in  on  the  programs  in  various 
ways.  He  may  make  a  direct  deal  with  the  drug  company  for  financial 
backing.  An  individual  research  grant  might  run  from  $5,000  upward 
of  $50,000,  enabling  a  doctor  with  good  prison  contacts  to  handily 
double  or  triple  his  regular  income. 

The  financial  exploitation  of  prisoners  by  the  drug  companies  bog- 
gles the  imagination.  For  income  tax  purposes,  it  is  all  carried  out 
in  the  name  of  sweet  charity.  To  cite  one  example :  in  California  the 
experiments  are  done  under  the  aegis  of  a  shadowy  outfit  called  the 
Solano  Institute  for  Psychiatric  and  Medical  Research,  SIMPR,  with 
headquarters  in  Vacaville  Prison,  set  up  as  a  nonprofit  corporation 
under  California's  charitable  trust  law. 

SIMPR's  income  rose  from  $47,000  in  1963,  its  first  year  of  opera- 
lion,  to  $266,000  in  1971.  It  is  in  fact  a  conduit  for  tax-exempt  pay- 
ments from  giant  pharmaceutical  concerns  including  Lederly,  Wyeth, 
Dow  Chemical,  to  medical  researchers  who  are  for  the  most  part  fac- 
ulty members  of  the  University  of  California. 

The  corporation  hires  convict  laboratory  technicians,  nurses,  para- 
medics for  wages  in  the  range  of  $5  to  $8  a  month,  about  one-hun- 
dredth of  what  free  personnel  would  command  in  these  positions.  Pay- 
ment to  the  prisoner-subjects  of  the  experiments  is  recorded  in 
SIMPR's  annual  financial  statements  as  "Benefits  to  recipients  under 
charitable  trust."  Over  a  nine-year  period,  these  have  totalled  $787,000. 
Thus,  assuming  the  drug  companies  would  have  had  to  compensate 
free-world  volunteers  at  ten  times  what  they  pay  convicts,  they  ob- 
tained some  $7.8  million  worth  of  research  for  their  $787,000.  All  this 
is  in  violation  of  the  California  constitution  which  specifically  prohib- 
its the  hiring  out  of  convict  labor  to  private  business  concerns. 

After  my  article  appeared  in  the  Atlantic,  the  media  made  a  bee- 
line  up  to  Vacaville  to  have  a  look  at  the  SIMPR  experiments. 

In  my  opinion,  they  were  given  a  snow- job  by  the  prison  authori- 
ties and  the  drug  companies.  All  we  saw  on  television  and  in  the  news- 
papers were  innocuous  looking  skin  patch  tests  and  the  like.  But  ac- 
cording to  Dr.  Sheldon  Margen,  Chairman  of  the  Department  of  Nu- 
tritional Sciences  at  the  University  of  California,  some  of  the  experi- 
ments are  atrociously  painful  and  dangerous,  they  would  never  be 
approved  by  the  University's  committee  on  human  experimentation. 

All  of  this  hiring  of  these  convicts  at  these  disgraceful  wages  and 
the  hiring  of  convicts'  bodies  for  these  experiments  is  in  clear,  direct 
violation  of  the  California  constitution. 

Senator  Kennedy.  Why  hasn't  the  State  done  something  about  it  ? 

Miss  MiTFORD.  I  don't  know.  Until  recently,  very  knowledgeable  men 
who  for  years  have  studied  prison  conditions,  were  unaware  of  the 
whole  operation.  They  did  not  know  the  extent  or  the  nature  of  it. 
Perhaps  now  they  will  take  some  action. 


796 

Senator  Kennedy.  Did  Dr.  Margen  do  a  review  of  the  experiments  ? 

Miss  MiTFORD.  He  did.  He  went  through  the  annual  research  review 
protocols.  Here  is  what  he  told  me. 

He  said  that  among  the  hazards  of  STMPR  experiments  described 
in  the  California  Department  of  Corrections  Research  Review — a  pub- 
lication of  the  California  Department  of  Corrections  which,  to  me, 
meant  very  little,  because  I  don't  understand  the  medical  jargon — he 
said,  are  cardiac  failure,  total  loss  of  blood  flow  resulting  in  neurolog- 
ical damage  and  loss  of  fingers,  fungus  infection,  allergic  reactions. 

The  Organic  Phosphates  Toxicity  Study  involves,  he  said,  use  of  the 
most  dangerous  and  poisonous  of  all  pesticides.  He  added : 

If  the  researchers  really  believe  these  experiments  are  safe  for  humans,  why 
don't  they  try  them  out  in  their  own  labs  on  students?  Because  they  know  the 
University  would  never  permit  this — and  furthermore  it  would  never  occur  to 
them  to  do  these  things  to  people  they  regard  as  colleagues  and  social  equals. 
They  look  on  men  behind  bars  as  something  less  than  human. 

Government  agencies,  HEW  and  FDA,  supposed  watchdogs  of  the 
public  health,  take  the  position  that  their  writ  does  not  run  behind 
prison  walls.  I  was  told  by  Dr.  D.  T.  Chalkley,  chief  of  the  Insti- 
tutional Relations  Branch,  Division  of  Research  Grants  at  HEW — 
incidentally,  he  is  also  the  author  of  the  Institutional  Guide  of 
HEW — that  HEW  regulations  requiring  "informed  consent''  and 
other  safeguards  for  human  subjects  do  not  apply  to  private  industry 
research. 

Furthermore,  HEW  does  not  even  maintain  a  list  of  prisons  in  which 
HEW-financed  research  is  in  progress,  nor  does  it  police  the  activities 
of  its  own  researchers.  For  example,  Dr.  Chalkley  was  not  aware  that 
prisoners  are  required  to  sign  an  illegal  waiver  of  their  rights  in 
cholera,  typhoid  and  viral  diarrhea  studies  currently  underway  at  the 
Maryland  House  of  Corrections  under  a  grant  from  National  Insti- 
tutes of  Health,  a  division  of  HEW. 

Doctors  with  whom  I  have  spoken  are  unanimously  of  the  opinion 
that  FDA  regulations  requiring  human  testing  before  a  drug  can  be 
marketed  are  sound  and  necessary.  They  point  to  the  notorious  greed 
and  often  criminal  irresponsibility  of  the  drug  industry,  as  evidenced 
by  the  Thalidomide  disaster  and  the  sloppy  fashion  in  which  the 
birth  control  pill  was  released  for  mass  consumption  with  horrible 
consequences  for  many  women. 

Who,  then,  should  be  the  human  subjects  ? 

My  suggestions  are  two-fold.  1)  As  one  consequence  of  the  current 
prison  rebellion  prisoners  across  the  country  are  demanding  the  right 
to  organize  and  bargain  collectively  for  prevailing  industrial  wages 
in  the  many  jobs  they  perform.  This  effort  is  being  coordinated  by  the 
Prisoners  Union,  a  national  organization  with  headquarters  in  San 
Francisco.  I  urge  this  committee's  support  for  unionization  of  prison- 
ers, which  would  restore  their  human  dignity  and  make  it  unnecessary 
for  them  to  barter  their  bodies  for  cigarette  and  candy  money. 

2)  Spokesmen  for  the  drug  industry  claim  that  participation  in 
research  is  a  rew^arding  experience  for  prisoners,  who  feel  they  are 
expiating  their  crimes  and  helping  mankind.  How  much  more  re- 
warding, then,  might  it  be  for  the  stockholders  in  the  giant  drug  com- 
panies to  volunteer  for  this  noble  cause,  since  they  stand  to  gain  fi- 
nancially and  could  incidentally  expiate  the  many  crimes  of  the  com- 
panies in  which  they  have  invested. 


797 

I  believe  that  it  is  to  this  source,  drug  company  stockholders,  that 
researchers  should  look  for  human  volunteers. 

Senator  Kennedy.  Thank  you  very  much.  Miss  Mitf ord.  ^Ir.  Cowan  ? 

STATEMENT  OF  GEOFFREY  COWAN  AND  AILEEN  ADAMS,  COM- 
MUNICATIONS LAW  PROGRAM,  UCLA  SCHOOL  OF  LAW,  LOS 
ANGELES,  CALIF. 

Mr.  Conway.  Thank  you  for  inviting  us  to  be  with  you.  I  am  g(>ing 
to  read  the  first  part  of  our  statement  and  Aileen  Adams  will  read  the 
second. 

Assisted  by  a  grant  from  the  Fund  for  Investigative  Journalism  and 
a  "to-whom-it-may-concern"  letter  of  introduction  from  McCalls 
magazine,  we  spent  eight  weeks  during  the  summer  of  1971  visiting 
drug  testing  sites  in  eleven  states.  We  expected  at  the  outset,  to  un- 
cover isolated  examples  of  human  abuse ;  but  instead  of  a  few  specific 
scandals,  we  found  a  dominant  pattern  of  human  exploitation. 

We  expected  to  find  that  the  worst  experiments  were  sponsored  by 
pharmaceutical  companies ;  instead  w^e  found  that  the  most  outrageous 
tests  are  often  funded  by  the  Federal  Government.  And,  we  should 
add,  we  expected  that  our  article  would  be  published  by  McCalls;  but 
instead  it  was  published  by  Norman  Cousin's  new  magazine.  World. 

We  would  offer  a  copy  of  that  for  the  record. 

Senator  Kennedy.  It  will  be  so  admitted. 

[The  article  referred  to  follows :] 


798 


The  American  Scene 


2A  PEG: 
:':917  Vi/E  TEST 
^I'^'Jrf'  DRUGS 

by  Aileen  Adams  and 
Geoffrey  Cowan 

Prison  inmates  and  other 
"volunteers"  are  used  to 
determine  if  drugs  are  safe 
for  the  rest  of  us.  The 
results  are  sometimes  fatal. 


A  cheerful,  cartoon-studded  brochure 
entitled  Malaria  Volunteer  invites 
inmates  at  the  Jackson  County,  Missouri, 
jail  to  join  a  six-week  program  that  pro- 
vides "additional  food,  ice  cream,  fruit 
juice,  improved  quarters,"  and  a  $50 
honorarium.  On  completing  the  pro- 
gram, participants  are  awarded  a  di- 
ploma-sized "Certificate  of  Merit,"  suit- 
able for  framing,  commending  them  for 
their  "display  of  social  responsibility  and 
unselfishness."  In  return  they  must  sub- 
mit to  infection  with  a  live  malaria  virus, 
as  subjects  to  test  new  cures  being  de- 
veloped by  the  United  States  Army. 

The  Jackson  County  inmates  are  typi- 
cal of  tens  of  thousands  of  people  in  the 
United  States  who  each  year  "volunteer" 
to  test  the  new  drugs  being  developed 
by  pharmaceutical  companies  and  the 
United  States  government.  Poor,  often 
black,  institutionalized  in  public  facili- 
ties including  prisons,  hospitals,  and 
homes  for  tlie  mentally  retarded,  they 
are  accessible  and  often  can  be  per- 
suaded to  participate  in  virtually  any  ex- 
periment recommended  by  a  physician. 

Such  tests  frequently  have  been  con- 
ducted with  discomforting,  and  some- 
times fatal,  results.  This  past  summer  a 
test  by  the  United  States  Public  Health 
Service  made  national  headlines  when 
the  Associated  Press  revealed  that  431 
black  men  from  Tuskegee,  Alabama, 
most  of  them  poor  and  uneducated, 
were  deliberately  permitted  to  suffer  the 
ravages  of  syphilis  for  forty  years  with- 
out benefit  of  such  modem  drugs  as 
penicillin.  According  to  doctors  in 
charge  of  the  study,  at  least  28,  and  per- 
haps close  to  100,  of  the  men  died  as  a 
direct  result  of  untreated  syphilis— all  in 
the  interests  of  medical  science.  The 
news  provoked  a  wave  of  indignation. 

Unpublicized  experiments  on  similar 
test  populations  are  now  occurring  al- 
most daily  throughout  the  United  Stales, 
for  human  experimentation  is,  and  will 
continue  to  be,  an  important  American 
growth  industry— fueled,  ironically,  by 
the  requirements  of  recent  liberal  legis- 
lation. Tlie  Harris-Kefauver  drug  law  of 
1962,  enacted  after  the  thalidomide  dis- 
aster, requires  pharmaceutical  compa- 
nies to  conduct  three  stages  of  human 
trials  before  the  Food  and  Drug  Admin- 
istration allows  a  drug  to  be  marketed. 
According  to  FDA  records,  more  than 
3000  drugs  currently  are  being  tested, 
and  more  than  500  of  them  were  first 
tested  on  humans  in  1971.  In  addition, 
federal  programs,  on  matters   ranging 

Aileen  Adams  and  Geoffrey  Cowan,  who 
are  wife  and  husband,  spent  six  weeks  re- 
searching drnp,  testing  under  a  grant  from 
the  Fund  for  Investigatioe  Journalism.  Ms. 
Adams  is  a  student  at  the  UCLA  School  of 
Law,  and  Mr.  Cowan  is  director  of  tha 
schooUs  Communications  Law  Program. 


from  population  control  to  cancer,  fi- 
nance researchers  who  utilize  test  sub- 
jects to  develop  new  cures.  Thus,  with 
the  lofty  intention  of  discovering  safe, 
efiFective  medical  cures,  we  have  created 
a  new  form  of  public-service  employee: 
the  human  guinea  pig. 

Though  all  of  us  who  use  drugs  are 
in  their  debt,  no  one,  including  the  FDA, 
has  attempted  to  take  a  hard  look  at  the 
test  subject.s  themselves.  Physicians  have 
developed  a  vast  literature  on  the  ethics 
of  human  experimentation,  but  such  re- 
ports never  examine  one  ethical  con- 
sideration that  would  seem  paramount: 
the  background  or  class  composition  of 
the  people  on  whom  the  most  dangerous 
tests  are  conducted.  After  visitincf' drug- 
testing  facilities  in  eleven  states,  we  con- 
cluded that  the  people  who  become  "vol- 
unteers" for  the  early,  riskiest  stage  of 
drug  development  tend  to  be  "captive 
populations"  institutionalized  in  prisons, 
public  hospitals,  and  homes  fo/  the 
mentally  retarded;  they  also  tend  to  be 
poor  and  ill-educated. 

Medical  testing,  of  course,  is  not  gen- 
erally a  simple  matter  of  exploiters  and 
e.xploited.  For  many  sick  volunteers, 
such  as  cancer  patients,  experimental 
cures  offer  the  only  hope.  By  law  even 
healthy  test  subjects  must  be  told  what 
they  are  letting  themselves  in  for.  For 
one  reason  or  another  they  do  it  anyway. 
At  the  Jackson  County  jail,  for  instance, 
the  Malaria  Volunteer  brochure  warns 
participants  to  expect  "fever,  chills, 
nausea,  vomiting,  and  headaches";  and 
it  notes  that  there  is  a  "real  possibility" 
of  subsequent  relapse.  After  living 
through  a  week  of  violent,  uncontrol- 
lable hot-and-cold  shivers,  many  volun- 
teers wish  they'd  never  heard  of  malaria. 
Nevertheless,  drug  researchers  at  the 
jail  had  no  trouble  finding  107  malaria 
volunteers  last  year. 

"Money,  that's  why  they  do  it,"  .says 
Steve  Ward,  a  wiry  black  inmate  who 
worked  full  time  for  the  project.  Inmates 
run  up  huge  gambling  debts  in  jail,  he 
explains,  and  the  malaria  money  offers 
the  only  escape  from  what  amounts  to  a 
kind  of  slavery  to  their  cellblock  credi- 
tors. Others  apparently  enter  the  pro- 
gram simply  to  escape  their  tedious, 
cramped  existence  in  the  jail. 

State  prisons  are  probably  the  most 
widely  used  institutions  for  the  first  stage 
of  medical  experimentation,  partly  be- 
cause they  oflFer  a  ready  supply  of 
healthy  volunteers.  Though  testing  is 
generally  not  allowed  by  the  Federal 
Bureau  of  Prisons,  more  than  half  the 
states  and  countless  cities  permit  testing 
on  their  prison  inmates.  FDA  officials 
estimate  that  more  than  90  per  cent  of 
the  first  trials  for  drug  safety  in  humans 
are  conducted  on  prisoners. 

Prison  o£Bcials  we  talked  with  empha- 


20 


799 


i^{  lodii  oomit; 


sized  the  variety  of  ways  that  prisoners 
benefit  from  testing  programs.  Louie 
Wainwright,  the  chief  of  the  Florida 
Division  of  Corrections,  points  out  that 
prison  hospitals  are  generally  under- 
financed and  neglected  in  major  respects. 
Drug  companies  which  pay  for  the  tests, 
says  Wainwright,  contribute  signifi- 
cantly to  the  improvement  of  substand- 
ard medical  facilities  at  prisons.  Wain- 
wright's  former  research  assistant, 
Charles  Eichman,  says  that  he  changed 
his  negative  opinion  of  drug  testing 
when  he  learned  that  the  intensive 
physical  examinations  given  each  par- 
ticipant were  actually  saving  lives.  "One 
inmate  volunteered  for  an  aspirin  study," 
Eichman  recalls,  "and  his  doctor  found 
he  had  cancer."  "It's  the  only  legitimate j 
way  prisoners  here  can  earn 
money,"  says  the  young  nurse  who 
ran  the  Jackson  County  malaria 
testing  program.  "It  also  appeals 
to  their  sense  of  patriotism, 
because  they  know  they're 


"Poor,  often  black,  confined 
in  public  facilities,  tiicy  are 
easily  accessible  and  can 
be  persuaded  to  parlicipa^c 
in  virtually  any  experiment 
recommended  by  a  pEiysician." 


contributing  to  the  guys  in  Vietnam." 
But  some  prison  testing  programs 
have  been  riddled  with  abuses.  They 
have  been  linked  to  prison  drug  traffic, 
forced  homosexual  encounters,  injuries 
to  inmates,  and  highly  questionable  test 
results.  A  1968  government  study  of 
the  Holmesburg  Prison  in  Philadelphia 
found  that  inmate  workers  for  the  Uni- 
versity of  Pennsylvania  Medical  School 
testing  project  frequently  stole  and  sold 
drugs  used  on  various  experiments. 
Moreover,  since  the  testing  program  was 
the  prisoners'  principal  source  of  income 
—distributing  to  inmates  more  than  a 
quarter  of  a  million  dollars  each  year- 
it  gave  great  patronage  power  to  the  in- 
mate who  controlled  the  selection  of  test 
participants.  According  to  the  study,  at 
least  one  such  inmate,  a  fraud  artist,  used 
I  his  position  to  induce  men  to  serve  as  his 
homosexual  companions  for  fees  of  about 
$1600  a  year. 

No  one  can  estimate  how  many  cas- 
ualties there  may  have  been  from  prison 
testing.  Since  the  FDA  doesn't  interview 
inmates  directly  and  the  "release  forms" 
signed  by  test  participants  make  it  un- 
likely that  many  cases  will  reach  court, 
one  must  rely  on  anecdotal  impressions. 
According  to  the  report  on  the  Philadel- 
phia prison  system,  some  prisoners  "end- 
ed up  with  bodies  crazy-quilted  with 
different-colored  reactions  and  scars." 
Some  adverse  side  effects  may  not 
show  up  until  after  the  inmate  leaves 
prison.  Three  years  ago  thirty  inmates 
in  the  Nevada  state  prison  participated 
in  a  test  to  produce  Rhogam,  a  widely 
used  serum  designed  to  help  women  with 
Rh-negative  blood  deliver  healthy  ba- 
bies. The  inmates,  all  of  whom  were 
Rh  negative,  were  injected  with  Rh- 
positive  blood  to  help  them  develop  the 
antibodies   that  institute  the  Rhogam 


^1 /'.«:- PlilS® 


serum.  An  unfortunate  side  effect  of  the 
test  is  that  the  blood  of  the  participants, 
all  of  whom  are  Rh  negative,  perma- 
nently looks  as  if  it  is  Rh  positive.  If  any 
of  the  test  subjects  subsequently  needs 
a  transfusion,  therefore,  doctors  might 
mistakenly  give  him  a  fatal  transfusion 
of  the  wrong  blood  type.  Such  a  mix-up 
almost  occurred  recently  when  one  <rf 


World  12/5/72 


21 


800 


uie  Nevada  inmate-participants  tried  to 
commit  suicide  and  a  test  by  attendants 
at  the  prison  hospital  showed  his  blood 
to  be  Rh  positive.  Fortunately,  the  prison 
doctor  was  called  at  home  and  remem- 
bered that  the  inmate  had  been  a  test 
participant. 

There  are  also  reasons  to  doubt  the 
results  of  tests  conducted  in  prisons.  "If 
the  drug  comes  in  tablet  form,  you  can 
never  he  sure  they  take  it,"  says  the 
medical  director  of  the  Nevada  state 
prison  system.  "That's  why  I  prefer  in- 
jections." "Inmates  know  how  to  tongue 
a  pill,  cheek  it,  or  palm  it,  and  you  can't 
really  tell  whether  they  swallow  it," 
said  a  prison  guard. 

Ho>rKS  FOR  mentally  retarded  children 
are  favorite  testing  pi  .ices  for  new  drugs 
and  v.iccincs.  The  live-virus  nibeila  vac- 
cine for  German  measles  was  first  tested 
at  the  Arkansas  Children's  Colony,  a 
school  for  the  mentally  retarded  near 
Conway,  Arkansas.  Rather  than  contend- 
ing tliat  tlie  vaccine  would  particularly 
booefit  the  children,  researchers  from 
the  National  Institute  of  Health  ex- 
jjlained  that  the  test  required  "carefully 
controlled  conditions"  where  "suscepti- 
ble persons  are  shielded  from  those  who 
linve  been  vaccinated,"  and  they  chose 
the  school  because  it  was  in  a  rural 
selling  and  the  700  students  "reside  in 
widcl)'  scattered  cottages  that  are  func- 
tionally independent." 

The  mentally  retarded  children  who 
are  used  for  hepatitis  experiments  at  the 
A\'illo\vl)rook  Stale  School  in  Staten  Is- 
land, Ne\v  York,  are  among  the  most 
famous  test  subjects  in  the  country.  In 
I')07  the  late  Senator  Robert  Kennedy 
nmovcied  one  reason  why  children  at 
^^'illo\vb^ook  «-ere  willing  participants. 
Paienls,  he  discovered,  had  been  told 
that  the  school  was  too  crowded  and 
that  their  child  couldn't  get  in— unless 
the  parents  would  agree  to  let  the  young- 
ster join  the  school's  hepatitis  testing 
program. 

Nearly  3500  mentally  retarded  chil- 
dren over  the  past  eighteen  years  have 
I'-.-'i)  iiiiic'tod  wilh  hepatitis  virus  by 
p'l .  sici  VIS  ,it  Willowbrook.  The  children 
lli<~n  pailicipale  in  tests  designed  to  ana- 
lyze; the  '.lisease  and  to  find  an  effective 
cure.  Critics,  like  Harvard  Medical  School 
Professor  ICnieritus  Henry  K.  Beecher, 
call  it  a  moral  outrage  to  infect  mental 
retardates  in  order  to  search  for  a  cure. 
The  test's  director.  Dr.  Saul  Kingman, 
disagrees.  He  contends  that  unsanitary 
habits  of  ment.al  retardates  ensure  that 
most  of  I  he  children  would  get  hepatitis 
anyway  and  that  it  is  therefore  in  their 
interest  to  be  treated  by  a  highly  experi- 
enced stair  under  controlled  conditions. 

During  the  past  two  years,  the  Florida 
Mental  Retardation  Division  has  become 


HOW  LO^^C.  DOFS  IT  LASTJ 


ky  ■  I*.,  an*  Mn«)  ^wnrf  *^>kh  w 


unusually  hospitable  to  drug  investiga- 
tors. With  the  assistance  of  Dr.  Charles 
Weiss— a  former  research  official  at  Parke 
Davis  &  Co.,  who  is  now  a  dnig  investi- 
gator and  the  medical  consultant  to  the 
chief  of  the  division— products  ranging 
from  influenza  vaccine  to  pinworm  medi- 
cation have  been  tested  on  many  of  the 
several  thousand  mentally  retarded  chil- 
dren interned  at  the  division's  eight  Sun- 
land  training  centers. 

An  important  current  experiment  at 
the  Sunland  Center  in  Fort  Myers .  in- 
volves a  vaccine  for  Shigella,  a  severe 
fonn  of  dysentery  that  occurs  primarily 
in  custodial  institutions.  Under  the  au.s- 
pices  of  the  U.  S.  Center  for  Disease  Con- 
trol, the  vaccine  has  already  been  tested 
on  prisoners  and  mentally  retarded  chil- 
dren in  Maryland.  The  vaccine  was  next 
scheduled  for  use  at  Willowbrook,  ac- 
cording to  physicians  involved  in  the 
present  study,  but  the  CDC  moved  the 
test  to  Fort  Nlyers  when  poor  conditions 
at  Willowbrook  became  a  public  cause 
celdhre  in  New  York  City  last  spring. 
While  the  incidence  of  Shigella  is  lower 
in  Sunland  than  in  many  other  institu- 
tions, CDC  officials  explain  that  they 
chose  the  Fort  Myers  facility  "because 
of  the  considerable  cooperation  from  Dr. 
Weiss  and  his  department." 

Financial  phessuhes  have  led  some 
municipal  hospitals  to  set  up  entire  units 
devoted  to  evaluating  new  drugs.  For 
example,  under  a  contract  originally  ne- 
gotiated with  the  city  of  Newark,  New 


Jersey,  in  1963,  the  huge  Swiss  drug  com- 
pany Hoffmann-La  Roche  imtil  recently 
maintained  and  staffed  a  complete  ward 
on  tlie  fourteenth  floor  of  Martland  Medi- 
cal Center.  Martland  happened  to  be  the 
only  hospital  easily  accessible  for  most  of 
the  city's  poor  residents.  The  drug  com- 
pany paid  Newark  $25,000  for  the  use  of 
the  city  hospital,  according  to  a  1966  re- 
negotiated contract,  in  return  for  which 
the  company,  at  its  own  expense,  pro- 
vided care  for  patients  and  conducted 
research  on  new  drugs.  Originally,  pa- 
tients apparently  were  assigned  to  the 
drug  company's  floor  on  a  random  basis, 
without  being  told  that  they  were  enter- 
ing a  company-financed  testing  unit.  Bet- 
ter procedures  were  adopted  in  1966 
when  operation  of  the  hospital  was  taken 
over  by  the  New  Jersey  College  of  Medi- 
cine, and  the  entire  unit  was  moved  to  a 
private  hospital  in  April  1971. 

Until  its  operations  came  to  public 
light  in  1971,  the  Pentagon's  Nuclear  De- 
fense Agency  for  eleven  years  had  fi- 
nanced a  University  of  Cincinnati  study 
of  the  effects  of  atomic  radiation  on  hu- 
man beings.  Under  an  $850,000  contract, 
the  university's  medical  .school  treated 
111  terminal  cancer  patients,  who  were 
told  that  there  was  a  good  chance  the 
treatment  would  reduce  the  size  of  their 
tumors  and  relieve  some  of  the  pain.  A 
number  of  radiologists  disputed  the  ther- 
apeutic value  of  the  treatment  and 
charged  that  it  was  used  as  a  device  to 
obtain  participants  in  the  Defense  De- 
partment study.  All  but  three  of  the  pa- 


22 


801 


"Evetx  healthy  test  subjects  must  be  told 
wJiat  they  are  in  for.  For  one  reason  or 
another  tliey  do  it  anyway." 


tionfs  were  clinrity  cases  from  Cincinnati 
C;(Mici;il  Hdspitnl.  Most  had  I.Q.'s  below 
90  (  100  is  average),  and  their  average 
IcnKlli  of  schooling  was  six  years. 

]^vcn  some  of  the  most  important  (and 
nltiniatcly  life-saving)  tests  conducted  in 
public  hospitals  involve  significant  risks. 
■(  lionph  nc\  <M  fully  .studied  for  use  in  in- 
f.Tuts,  tiic  antibiotic  Chloramphenicol  for 
.several  years  was  widely  used  as  a  pro- 
phylactic t(i  counteract  the  high  infection 
rale  in  premature  newborns— until  two 
studios  by  Dr.  Joan  Hodgman  revealed 
tli;it  liie  drug  appeared  to  be  killing  a 
sijinificaut  number  of  infants  to  whom  it 
vv-as  administered.  Roth  studies  were 
conduclixl  in  ihe  Premature  Center  of 
Los  Aiu'.elrs  County  Hospital,  where  vir- 
tually ail  of  Ihc  infant  participants  were 
from  poor  families,  most  of  them  black 
(M'  Ch'cano. 

The  first  study  demonstrated  that  at 
.som<>  dosage  lexels  Cloramphenicol  is 
CNlrcniely  toxic  for  premature  infants. 
'I'ho  study  also  found  that  antibiotics  did 
not  Ir>\\Tr  llie  mortality  level  when  given 
as  a  prophylactic  to  certain  healthy  pre- 
matures. Consequently  the  Premature 
Center,  concluding  that  the  potential  ri.sk 
otilwcighed  the  possible  benefits,  discon- 
liniird  the  use  of  the  drug  for  helping 
pveinalures. 

ndieving  that  "Chloramphenicol 
would  still  be  useful  for  the  treatment 
(>f  infected  prematures  if  a  safe  dosage 
schedule  were  established,"  Dr.  Hodg- 
man and  lier  colleagues  then  conducted 
a  second  test.  This  time  they  gave  vary- 


ing dosages  of  Chloramphenicol  to  126 
prematures,  most  of  whom  were  "in  good 
condition,"  but  who  had  been  exposed 
to  staphylococcal  infection.  Six  of  the 
infants  developed  symptoms  associated 
with  Chloramphenicol  toxicity— such  as 
refusing  to  nurse,  regurgitating  a  for- 
mula, abdomens  becoming  distended, 
loose  green  stools,  and,  within  twenty- 
four  hours  after  the  appearance  of  toxic 
symptoms,  becoming  ashen  gray  and 
lethargic.  Three  of  the  infants  who  de- 
veloped these  symptoms  survived;  three 
died.  Although  the  deaths  may  have 
been  due  to  other  causes,  the  study  con- 
cluded that  "it  is  possible  that  these 
three  infants  represent  a  toxic  reaction 
[to  Chloramphenicol]  at  relatively  low 
blood  levels."  Partly  as  a  result  of  Dr. 
Hodgman's  test.  Chloramphenicol  now 
is  seldom  given  to  premature  infants, 
and  then  only  in  very  small  dosages. 

Public  hospital  patients  are  rarely  in 
a  position  to  evaluate  the  merits  of  an 
experiment  that  they  are  asked  to  join. 
In  her  ofRce  at  New  Orleans's  Charity 
Ho.spital,  Dr.  Margaret  Smith,  who  is  a 
member  of  the  Public  Health  Service's 
Committee  on  Immunology  Practices, 
described  the  parents  from  whom  she 
had  received  "informed  consent"  for  their 
children  to  participate  in  a  meningitis 
study:  "Most  of  the  parents  are  unedu- 
cated blacks.  Some  of  them  can't  read— 
they're  not  very  sophisticated  people." 

In  defense  of  public-hospital  tests.  Dr. 
Smith  contends  that  according  to  nurses 
at  the  hospital,  "public  patients  get 
much  better  care  when  they're  part  of 
a  drug  study."  While  undoubtedly  true, 
this  explanation  raises  as  many  ques- 
tions as  it  answers.  Because  treatment 
at  public  hospitals  and  prisons  is  often 
substandard,  physicians  may  justifiably 
beheve  that  the  medical  benefits  of  test- 
ing outweigh  the  risks.  But  is  it  just  to 
ask  the  poor  to  accept  the  risks  of  medi- 
cal experimentation  in  order  to  obtain 
adequate  health  care? 

A  similar  problem  arises  with  the  legal 
requirement  to  obtain  a  patient's  "in- 
formed consent"  before  beginning  the 
test.  Technically,  the  researcher  must 
clearly  explain  the  drug's  potential  risks 
and  the  available  alternative,  non-ex- 
perimental forms  of  medication.  Re- 
searchers often  find  it  easiest  to  obtain 
the  consent  of  poor  or  institutionalized 
populations.  More  than  one  drug  investi- 
gator told  us  that  their  poor  patients 
would  cut  a  finger  or  an  arm  off  without 
asking  questions  if  they  recommended 
it.  For  people  living  under  such  circum- 
stances, one  wonders  whether  the  phrase 
"informed  consent"  has  meaning. 

Yet  even  such  heretofore  acquiescent 
groups  are  beginning  to  resist  medical 
experimentation.  During  the  summer  of 
1969,  398  women  in  San  Antonio,  Texas, 


participated  in  a  test  designed  to  evalu- 
ate the  side  effects  produced  by  various 
kinds  of  oral  contraceptives.  Most  of  the 
women  were  Mexican-Americans  who 
had  been  referred  to  the  test  by  Planned 
Parenthood.  Activists  in  the  Chicano 
community  later  became  outraged  when 
it  was  revealed  that  seventy-six  of  the 
participants  had  been  given  a  placebo, 
or  sugar  pill,  instead  of  an  oral  contra- 
ceptive, and  that  seven  of  those  women 
had  become  pregnant.  Although  execu- 
tives at  Syntex  Laboratories,  sponsor  of 
the  test,  admitted  to  us  that  they  had 
anticipated  that  as  many  as  nine  of  the 
women  given  the  placebos  would  be- 
come pregnant,  apparently  none  of  the 
women  were  apprised  of  this  possibility. 
As  a  result  of  an  investigation  by  the 
Chicano-dominated  local  Community 
Action  Board  of  the  OEO,  which  pro- 
vides the  city's  Planned  Parenthood  pro- 
gram with  most  of  its  funds.  Planned 
Parenthood's  executive  director  re- 
signed, and  new,  tougher  guidelines  on 
human  experimentation  were  adopted. 
Finally,  this  spring,  after  a  prolonged  in- 
vestigation, the  FDA  officially  found 
that  in  several  crucial  respects  the  test 
had  been  improperly  conducted.  Two 
years  ago  a  proposed  test  of  the  am- 
phetamine-like drug  Nitalin  on  preschool 
children  of  Florida  migrant  workers  was 
abandoned  after  an  emotion-packed 
newspaper  article  on  it  generated  a 
series  of  local  protests.  And  in  1968,  in 
response  to  parents'  complaints,  the 
D.  C.  Children's  Clinic  in  Laurel,  Mary- 
land, stopped  testing  all  drugs  on  men- 
tally retarded  children  after  participants 
in  its  test  of  TriA  were  hospitalized  with 
serious  liver  dysfunctions. 

These  are  not  isolated  examples.  Sev- 
eral trends  in  American  society  are  com- 
bining to  complicate  the  task  of  finding 
suitable  and  willing  test  populations. 
Ethnic  groups  have  become  increasingly 
suspicious  of  those  who  wish  to  perform 
experiments— medical  or  social— on  mem- 
bers of  their  communities.  Increased  in- 
terest in  prison  reform  has  begun  to  focus 
attention  on  medical  problems  in  state 
and  local  prisons,  and  the  current  trend 
in  mental  retardation  is  to  confine  only 
hard-core  cases,  leaving  institutions  with 
fewer  good  subjects  for  tests  that  re- 
quire a  modicum  of  intelligence. 

Nevertheless,  there  is  still  a  clear  need 
to  test  some  new  drugs  and  vaccines  on 
human  subjects.  Few  would  contest  the 
importance  of  the  development  in  recent 
years  of  drugs  and  vaccines  to  treat  mat- 
ters ranging  from  birth  control  to  polio. 
Before  such  products  are  put  on  the 
market,  they  must  be  carefully  tested  to 
find  effective  dosages  and  to  make  cer- 
tain that  they  don't  produce  intolerable 
side  efi^ects.  Indeed,  many  leading  physi- 
cians and  government  officials  have  said 


World  12/5/72 


23 


802 


that  drugs,  particularly  those  used  on 
children  and  the  elderly,  may  require  a 
great  deal  more  testing  than  they  pres- 
ently receive.  Dr.  Harry  Shirkey,  chair- 
man of  the  Department  of  Pediatrics  at 
Tulane  University,  believes  that  prior  to 
receiving  FDA  approval,  all  drugs  that 
may  be  used  by  children  should  be  spe- 
cifically tested  on  children. 

Dr.  Shirkey  notes  that  many  if  not 
most  drugs  on  the  market  today  have 
not  been  tested  for  use  on  children;  such 
tests  are  expensive  and  present  enor- 
mous ethical  problems.  Although  these 
drugs  must  contain  a  warning  that  they 
are  not  approved  for  use  on  children, 
parents  who  have  successfully  used  the 
medication  sometimes  give  it  to  a  sick 
child,  and  it  is  not  uncommon  for  doc- 
tors who  have  heard  that  it  works  on 
children  to  prescribe  it.  Due  to  the  im- 
pact of  a  few  "pediatric  catastrophes" 
like  Chloramphenicol  and  the  efforts  of 
pediatricians  like  Dr.  Shirkey,  several 
high-ranking  FDA  officials  advocated 
the  adoption  of  a  regulation  stating  that 
no  new  drug  which  may  be  given  to 
children  can  be  approved  for  market- 
ing until  adequate  studies  have  been 
conducted  in  a  series  of  tests  in  various 
age  groups  up  to  fourteen  years.  This 
proposal  was  rejected,  however,  after 
the  pharmaceutical  industry  explained 
that  it  would  be  far  less  expensive  to 
agree  not  to  let  the  drug  be  used  on  chil- 
dren than  to  conduct  the  needed  experi- 
ments. FDA  officials  say  they  are  mak- 
ing every  effort  to  persuade  drug 
manufacturers  to  perform  such  tests  vol- 
untarily. 

As  ^viTH  MANY  arcas  in  which  scientific 
development  has  created  significant  ethi- 
cal and  political  dilemmas,  there  is  no 
single  simple  solution  to  the  problem  of 
testing  new  dnigs.  But  here  are  some  pos- 
sible reforms: 

•  Drug  companies  should  use  greater 
restraint  before  testing  new  drugs  that 
duplicate,  with  minor  variations,  the 
functions  of  drugs  now  on  the  market. 

•  Medical  schools  and  the  scientific 
community  should  eiicoumgc  greater 
professional  responsibility.  Though  strict 
codes  of  research  ethics  have  been 
adopted  by  the  American  Medical  As- 
sociation, a  recent  study  found  that 
most  physicians  engaged  in  clinical  re- 
search never  studied  the  ethics  of  testing 
while  in  medical  school,  and  that  a  "sig- 
nificant minority"  place  personal  and 
scientific  achievement  ahead  of  their  re- 
sponsibility to  the  test  population. 

•  Institutions  where  new  drugs  are 
tested  should  establish  effective,  broadly 
based  review  committees  in  accordance 
with  rules  adopted  by  the  Food  and  Drug 
Administration  and  the  Public  Health 
Service.  Though  such  committees   are 


now  required  by  law,  the  Food  and  Drug 
Administration  makes  no  systematic  ef- 
fort to  ensure  that  they  are  established 
and  function  effectively.  These  commit- 
tees would  examine  the  scientific  merits 
of  proposed  tests  and  protect  the  rights 
of  test  subjects.  They  should  be  com- 
posed of  clergymen,  lawyers,  and  com- 
munity representatives  as  well  as  scien- 
tists. The  Florida  prison  system's  new 
citizens'  committee  plans  to  visit  state 
institutions  regularly  and  ask  inmates  for 
their  comments  on  the  tests. 

•  Congress  could  adopt  legislation 
proposed  by  Sen.  Gaylord  Nelson  of  Wis- 
consin that  would  increase  the  govern- 
ment's role  in  the  selection  of  clinical  in- 
vestigators. Senator  Nelson  notes  that  at 
present,  since  drug  firms  select  their  own 
researchers  and  pay  them  to  accumulate 
data  demonstrating  that  a  new  drug  is 
safe  and  effective  enough  to  be  allowed 
on  the  market,  researchers  have  a  vested 
interest  in  highligliting  the  drug's  good 
points,  not  its  potential  dangers. 

•  Another  possible  legislative  reform 
would  provide  insurance  for  the  subjects 
of  medical  experimentation.  When  the 
details  of  the  Public  Health  Service's 
syphilis  test  were  revealed  last  summer, 
Alabama  senators  James  B.  Allen  and 
John  J.  Sparkman  introduced  legislation 
to  provide  financial  compensation  for 
test  participants  who  had  needle.ssly  suf- 
fered from  syphilis. 

None  of  these  reforms,  however,  will 
remove  the  special  risks  of  drug  e.xperi- 
mentation  from  the  powerless  segments 
of  our  society.  That  can  only  be  done  by 
having  each  citizen,  rich  or  poor,  under- 
take an  ethical,  and  perhaps  legal,  re- 
sponsibility to  share  the  risks  as  well  as 
the  benefits  of  the  experimentation.  Even 
if  Senator  Nelson's  bill  is  passed,  ques- 
tionable research  is  likely  to  be  con- 
ducted on  poor  and  institutionalized  sub- 
jects. Some  of  the  most  troubling  tests, 
including  the  Alabama  syphilis  experi- 
ment and  the  Cincinnati  cancer  test,  are 
financed  by  the  federal  government.  De- 
spite the  FDA's  finding  that  the  San  An- 
tonio test  cited  above  was  improper,  the 
physician  who  directed  it  is  now  con- 
ducting a  disturbingly  similar  study  un- 
der a  $2  million  contract  from  the 
Agency  for  International  Development. 

Furthermore,  funds  from  the  federal 
government,  like  funds  from  private  com- 
panias,  will  continue  to  seduce  the  ad- 
ministrators of  institutions  such  as  hos- 
pitals, prisons,  and  homes  for  mentally 
retarded  children.  In  the  absence  of  de- 
cent public  financing,  they  will  be  per- 
suaded that  it  is  humane  to  fund  an  in- 
stitution by  allowing  inmates  to  serve  as 
test  subjects.  And  the  poor  and  institu- 
tionalized, needing  money  themselves 
and  having  little  power  to  resist,  will 
often  succumb. 


803 

Mr.  Cowan.  We  have  been  asked  to  testify  this  morning  about  the 
problems  produced  by  testing  in  prisons,  and  so  we  shall.  But  we  ask 
this  committee  to  keep  in  mind  that  testing  in  prisons  represents  but 
one  highly  dramatic  manifestation  of  a  larger  phenomenon  which 
should  be  of  overriding  concern  to  this  Subcommittee  on  Health.  For, 
as  we  hope  our  testimony  will  help  to  demonstrate,  human  experi- 
mentation feeds  on  the  casualties  of  the  American  system  of  health 
care. 

To  some  extent  new  medical  cures  are  tested  on  people  from  all 
segments  of  society ;  but  the  earliest,  riskiest,  and  often  shoddiest  tests 
are  conducted  on  the  most  helpless  members  of  our  society — the  poor, 
the  retarded,  the  institutionalized.  In  addition  to  prisons,  favorite 
testing  places  include  public  hospitals  and  veteran's  hospitals,  nursing 
homes  and  homes  for  the  mentally  retarded — institutions  desperately 
in  need  of  money  and  resources  which  only  a  drug  company  or  the 
Government  can  provide. 

Yet  once  they  allow  drug  investigators  to  set  up  shop,  large  public 
institutions  like  prisons  and  mental  homes  seldom  have  the  capacity 
to  keep  tabs  on  their  work ;  and  the  enormous  new  flow  of  dollars  into 
an  impoverished  setting  has  an  almost  unlimited  capacity  to  corrupt 
those  whom  it  touches.  Wittingly  or  not,  the  institution  has  made  a 
Faustian  pact  with  would-be  purveyors  of  medical  progress. 

Therefore,  while  we  intend  this  morning  to  cite  several  specific 
problems  connected  with  prison  testing,  it  is  our  most  fundamental 
conclusion  that,  in  the  last  analysis,  the  blame  for  most  inhumane 
medical  research  rests  Avith  a  society  which  allows  its  poor  and  its 
institutionalized  to  live  in  such  desperate  circumstances — and  to  suffer 
from  such  abysmal  medical  care — that  they  would  welcome  a  case  of 
malaria  or  typhoid  or  scurvy. 

In  addition  to  the  shocking  physical  abuses  whose  lurid  details  have 
often  been  described,  prison  testing  produces  two  other  major  prob- 
lems which  we  shall  discuss  this  morning:  (1)  It  generally  does  not 
provide  test  subjects  with  the  kind  of  informed  consent  which  the 
law  requires;  and  (2)  it  tends  to  breed  corruption  and  conflicts  of 
interest  which  Government  and  private  officials  can  seldom  contain. 

The  extent  to  which  prison  drug  testing  plays  havoc  with  legal  and 
ethical  standards  of  informed  consent  can  perhaps  be  best  understood 
through  a  description  of  the  situation  at  the  Jackson  County  Jail  in 
Kansas  City,  Missouri,  where  malaria  tests  were  until  two  months  ago 
conducted  under  the  sponsorship  of  the  United  States  Army. 

The  Jackson  County  Jail  is  on  the  top  four  floors  of  the  county 
courthouse.  When  we  visited  it  in  the  summer  of  1971,  we  found  that 
it  was  hot,  and  cramped,  and  crowded.  Prisoners  have  little  or  no 
recreation.  The  last  meal  each  day  is  served  at  3 :00  p.m.  To  pass  the 
time  inmates  often  gamble,  occasionally  running  up  huge  debts.  Hav- 
ing no  money,  most  debtors  become  slaves  to  their  cellblock  creditors, 
performing  the  most  degrading  tasks.  And,  of  course,  there  are  bullies 
and  sexual  assaults,  and  fights;  and  for  some  there  is  fear  and  no  place 
to  hide. 

But  the  malaria  testing  program  offered  an  escape.  A  cheerful,  car- 
toon-studded brochure  entitled  "Malaria  Volunteer"  invited  inmates  to 
join  a  six- week  program  that  provide  additional  food,  ice  cream,  fruit 
juice,  improved  quarters,  and  a  $50  honorarium. 


804 

The  program  also  offered  constant  contact  with  female  nurses  and 
with  doctors  or  lab  technicians  who  were  part  of  the  outside  world.  On 
completing  the  program,  participants  were  awarded  a  diploma-sized 
"Certificate  of  Merit"  commending  them  for  their  "display  of  social 
responsibility  and  unselfishness." 

Of  course  the  brochure  also  made  it  clear  that  the  program  wasn't 
all  ice  cream  and  fruit  juice.  Participants  had  to  submit  to  infection 
with  a  live  malaria  virus.  "It  would  be  impossible  to  fully  compensate 
volunteers  for  the  discomfort  and  time  which  they  have  put  into  the 
project,"  the  brochure  stated,  and  it  explained  that  the  malaria  will 
cause  four  or  five  days  of  "fever,  chills,  nausea,  and  vomiting  and 
headaches."  It  also  noted  that  there  was  a  "very  remote  but  real  pos- 
sibility" of  relapse. 

Nevertheless,  drug  researchers  at  the  jail  had  no  trouble  finding  107 
malaria  volunteers  in  1971.  A  study  prepared  by  the  malaria  test's  chief 
investigators  concludes  that  in  addition  to  money,  inmates  were  moti- 
vated to  become  test  subjects  by  a  desire  for  better  living  conditions, 
by  fear  of  sexual  assault  in  their  cells,  and,  the  malaria  investigators 
claim,  by  a  belief  that  the  tests  are  patriotic  and  would  directly  help 
the  servicemen  in  Vietnam. 

In  our  opinion,  no  inmate  in  a  prison  like  Jackson  County  Jail  can 
ever  be  deemed  to  have  freely  given  the  kind  of  "informed  consent" 
which  is  required  by  the  Food,  Drug,  and  Cosmetic  Act  and  by  medical 
codes  of  ethics. 

The  investigators'  own  study  concluded  that  more  than  half  of  the 
volunteers  interviewed  "indicated  that  they  would  not  be  willing  to 
face  these  same  risks  when  free-living." 

Under  the  circumstances,  it  seems  reasonable  to  conclude  that  many 
prisoners  participated  in  the  tests  due  to  the  duress  caused  by  poor 
conditions  in  the  county  jail. 

But  we  do  not  intend  to  single  out  the  Jackson  County  Jail  as  a 
unique  institution.  Rather,  we  believe  that  that  jail  is  representative  of 
many — perhaps  most — prisons  where  drugs  are  tested.  In  institutions 
where  drug  tests  are  the  only  means  of  gainful  employment,  or  where 
they  offer  the  only  escape  from  inhumane  living  conditions  and  phys- 
ical or  sexual  assault,  prisoners  are  never  able  to  give  the  kind  of 
duress-free  informed  consent  which  the  law  and  medical  ethics  require. 

Ms.  Adams.  Prison  drug  tests  also  breed  a  kind  of  corruption  which 
neither  federal  officials  nor  private  review  committees  seem  able  to 
prevent.  Perhaps  the  best  known  allegations  of  corruption  and  conflict 
of  interest  in  prison  drug  tests  involved  Dr.  Austin  Stough.  Dr. 
Stough  was  forced  to  move  his  drug  testing  company  from  Oklahoma 
to  Alabama  in  1963,  after  it  was  disclosed  that  his  company  had  been 
paying  a  $1,000  monthly  fee  to  the  powerful  State  Senator  who  rep- 
resented the  district  w^here  the  state  prison  was  located. 

Six  years  later,  Dr.  Stough's  research  company  was  compelled 
to  leave  Alabama  partly  as  a  result  of  what  an  Alabama  Medical 
Association-appointed  committee  called  an  "unconscionable  situation" 
where  the  State's  senior  prison  physician  was  also  an  officer  of  the 
drug  company  Avhich  was  conducting  extensive  tests  on  prisoners. 

The  FDA  takes  the  position  that  it  has  now  eliminated  most  of 
what  it  calls  the  "bad  actors,"  or  so  we  were  assured  by  Dr.  Francis 
Kelsey,  Director  of  the  Scientific  Investigations  Staff  at  the  Office 


805 

of  Scientific  Evaluations,  when  we  interviewed  her  in  the  summer  of 
1971.  Unhappily,  our  research  indicates  that  the  FDA's  monitoring 
program  is  totally  inadequate,  that  the  FDA  has  never  developed 
a  complete  list  of  prisons  where  drugs  are  being  tested,  and  that  their 
assessment  that  there  are  no  "bad  actors"  is  largely  a  matter  of  defini- 
tion ;  they  think  there  are  no  bad  actors  because  they  have  no  one  who 
reviews  the  plays. 

Senator  Kennedy.  Is  the  Food  and  Drug  Administration  responsible 
for  monitoring  these  tests  ? 

Ms.  Adams.  Yes,  they  are  one  of  the  organizations  responsible.  Dr. 
Kelsey's  office  has  a  program  headed  by  Dr.  Alan  Lissock,  which  is 
called  Special  Survey  Monitor's  and  Sponsers  of  Clinical  Investi- 
gations. 

Dr.  Kelsey  told  us,  for  example,  that  Florida  was  in  the  process  of 
establishing  what  she  said  might  become  a  model  institutional  review 
system  designed  to  ensure  that  all  prison  tests  were  ethically  sound. 
The  role  and  composition  of  review  committees  is  especially  important 
in  view  of  the  fact  that  the  FDA  regulation  requiring  that  they  be 
established  was  the  FDA's  only  response  to  press  and  Senate  criticism 
in  1969  about  Dr.  Stough's  apparently  reckless  drug  testing  program 
in  Alabama  prisons. 

During  the  past  few  months,  however,  the  Associated  Press  has 
written  a  series  of  articles  about  the  program  which  have  led  Florida 
prison  officials  to  suspend  all  drug  tests.  According  to  the  Associated 
Press,  the  State  prison's  medical  director  has  received  $7,502  during 
the  past  two  years  for  his  role  in  connection  with  17  drug  projects 
in  the  prisons.  On  June  7,  1971,  for  example,  a  representative  of 
Parke,  Davis  Company  offered  him  a  $1,000  retainer  fee  for  work  in 
connection  with  a  proposed  18-month  experiment.  About  two  weeks 
later  the  medical  director  sent  a  memo  about  the  proposed  test  to 
the  prison  superintendent,  in  which  he  gave  his  assurance  that  "the 
study  can  be  conducted  with  little  hazard  to  the  inmate  volunteer." 

As  for  the  much-touted  institutional  review  committee,  it  is  riddled 
with  similar  conflicts  of  interest,  and  its  composition  appears  to  violate 
the  FDA  regulation  which  requires  that  drug  tests  be  reviewed  by  com- 
mittees which  are  completely  free  from  influence  or  pressure  by  the 
drug's  investigator. 

The  Protocol  Review  Committee,  as  it  is  called,  is  chaired  by  Dr. 
Charles  Weiss,  a  former  Parke,  Davis  clinical  researcher  who  joined 
the  University  of  Florida  faculty  in  1969.  Since  July,  1970,  Dr.  Weiss 
has  conducted  at  least  three  experiments  on  prisoners,  and  he  has 
served  as  a  member  of  the  board  of  directors  of  the  Peninsular  Test- 
ing Co.,  which  during  the  same  period  has  used  inmates  in  some  28 
tests.  While  Dr.  Weiss  says  that  he  abstains  from  voting  on  tests  where 
he  is  the  principal  investigator,  he  is  the  dominant  member  of  the 
committee,  and  he  has  told  us  that  he  helped  select  the  committee's 
other  members. 

A  similar  experience  with  the  Oklahoma  prison  system  demonstrated 
the  ineptitude  of  a  prestigious  local  review  committee  and  the  self- 
professed  helplessness  of  the  FDA. 

Drug  testing  at  the  McAlister,  Okla.,  prison  has  been  the  subject  of 
some  concern  for  several  years,  even  since  Dr.  Stough's  drug  research 
company  was  forced  to  leave  the  State.  After  Dr.  Stough's  departure. 


93-999  O  -  73  -  pt.  3  --  2 


806 

the  State  arranged  for  all  testing  to  be  run  through  the  State  univer- 
sity— which  gets  $75,000  a  year  in  return — and  a  Medical  Research 
Commission  was  established  to  make  certain  that  all  drug  tests  are 
ethical.  The  Medical  Kesearch  Commission's  membership  is  designated 
by  statute,  and  it  is  currently  chaired  by  Dr.  Leonard  Eliel,  executive 
vice  president  of  the  University's  Medical  Center. 

When  we  visited  Oklahoma  in  August  of  1971,  we  discovered  that 
the  Commission's  requirement  that  the  research  staff  be  totally  separate 
from  the  prison's  medical  staff  was  being  violated.  The  prison's  phy- 
sicians had  all  resigned  several  months  earlier,  we  learned,  and  the 
only  person  serving  as  prison  physician  was  Dr.  Evensen,  the  director 
of  the  prisoner's  drug  research  unit.  We  immediately  brought  this 
information  to  Dr.  Eliel's  attention,  but  he  refused  to  believe  us,  and 
on  September  9, 1971,  wrote  us  that  "at  no  time,  to  our  knowledge,  liad 
Dr.  Evensen  acted  as  the  prison  physician.''  Once  it  seemed  clear  that 
no  action  would  be  taken  by  the  Research  Commission,  we  decided  to 
bring  the  matter  to  the  attention  of  the  FDA. 

This  seemed  a  proper  matter  for  FDA  concern  since  45  drug  tests 
a  year  are  conducted  in  ^IcAlister  prison  and  the  FDA  has  the  respon- 
sibility for  approving  drug  investigators  and  research  protocols, 
for  assuring  that  test  subjects  receive  appropriate  safeguards  and 
for  ascertaining  the  effectiveness  of  institutional  review  committees. 
But  FDA  officials  said  that  they  were  helpless  to  act. 

Then  in  late  December,  1971,  we  received  a  letter  from  Dr.  Eliel, 
acknowledging  that  our  information  had  been  correct  all  along.  He 
wrote : 

"As  you  may  know,  there  has  been  a  change  of  Avardens  at  the  peni- 
tentiary. We  were  able  to  learn  from  the  new  warden  that  Dr.  Even- 
sen  was  in  fact  a  part-time  prison  physician  during  the  10  months 
prior  to  his  resignation.  This  is  contrary  to  ^ledical  Research  Com- 
mission policy  and  would  not  have  been  permitted  had  we  known  of 
this  arrangement." 

With  such  a  mixture  of  official  ignorance  and  governmental  power- 
lessness,  one  can  only  wonder  whether  anyone  is  truly  protecting 
prisoners'  rights. 

We  offer  no  single  solution,  but  we  favor  the  following  reforms; 
some  of  which  can  be  accomplished  by  the  FDA  and  the  medical 
profession,  some  by  pharmaceutical  companies,  some  by  Congress, 
and  some  only  by  a  concerned  public : 

1 )  There  should  be  fewer  tests.  As  Dr.  William  Stewart,  the  former 
Surgeon  General  who  is  now  Chancellor  of  the  Tulane  INIedical 
School,  told  us,  "lots  of  drugs  are  so  marginal  they  don't  have  to 
be  developed  at  all." 

Senator  Kennedy.  Are  these  tests  done  for  medical  reasons  or  com- 
mercial reasons  ?  Have  you  got  any  breakdown  on  that  ?  Are  they  al- 
legedly done  for  any  specific  reasons?  Are  they  all  for  commercial 
or  scientific  research  ? 

^fs.  Adams.  I  think  they  are  for  both.  We  brought  with  us  the 
protocols  that  were  used  in  the  Alabama  prison  tests.  They  have  a 
breakdown  of  the  drug  companies  involved  and  the  types  of  tests 
done.  We  will  give  them  to  the  Committee  Staff  for  inclusion  in  the 
record. 


807 

2)  The  level  of  health  care  and  of  general  conditions  in  the  Na- 
tion's prisons  should  be  improved.  Ethical  drug  tests  can  only  take 
place  in  decent  institutions  where  other  equivalent  forms  of  com- 
j>ensation  are  also  available. 

3)  New  methods  should  be  devised  to  ensure  that  informed  con- 
sent has  been  freely  given  by  inmate  volunteers.  Pharmaceutical  com- 
panies as  well  as  the  FDA  should  have  clear  responsibility  for  ensur- 
ing that  testing  institutions  are  providing  the  kind  of  informed 
consent  which  medical  ethics  and  the  law  require. 

4)  Participants  in  all  drug  tests  should  be  insured  by  the  sponsor, 
perhaps  through  a  form  of  no-fault  insurance. 

5)  The  FDA  should  assume  the  responsibility  for  thorough  super- 
vision of  testing  institutions  and  provide  mechanisms — including  ac- 
cess to  appropriate  records — by  which  concerned  citizens  can  help 
ensure  that  prison  investigators  are  complying  with  the  law. 

6)  The  FDA  should  take  an  active  role  in  ensuring  that  truly  ef- 
fective, independent  and  broad-based  review  committees  are  estab- 
lished, and  that  such  committees  perform  the  aggressive  on-going 
function  which  are  called  for  by  the  FDA's  regulation. 

7)  New  methods  of  instantaneous,  world-wide  data  collection 
should  be  established  so  that  Government  officials  and  the  medical 
profession  may,  as  rapidly  as  possible,  learn  when  apparently  isolated 
adverse  drug  reactions  form  a  comprehensive  pattern. 

8)  Finally,  we  believe  that  a  new  ethic  must  be  developed  in  which 
those  who  stand  to  profit  from  drug  research  share  the  risks  of  such 
research.  INIany  citizens  now  regard  it  as  a  civic  duty  to  donate  blood 
to  the  Red  Cross,  and  society  expects  citizens  to  share  responsibility 
for  jury  duty. 

Where  truly  important  medical  innovations  are  involved,  we  sus- 
pect that  it  would  be  possible  to  find  willing,  healthy  volunteers  from 
the  free  society. 

Senator  Kennedy.  Thank  you  for  your  very  helpful  testimony.  Let 
me  ask  you  some  questions. 

Do  you  think  that  prisoners  ought  to  participate  in  the  testing 
at  all? 

Miss  MiTFORD.  No ;  I  don't.  I  don't  think  there  could  be  such  a  thing 
as  informed  consent  in  prisons  today.  It  is  my  belief  that  it  is  a  viola- 
tion of  national  law  to  do  that.  I  should  like  to  add,  also,  that  in  other 
civilized  countries,  this  is  an  unknown  thing.  For  example,  in  Eng- 
land, it  would  be  unthinkable. 

Senator  Kennedy.  They  don't  have  any  research  experimentation 
in  England  at  all  ? 

Miss  MiTFORD.  It  would  be  totally  illegal. 

Senator  Kennedy.  As  a  result  of  your  review  of  this,  why  do  you 
think  the  prisoners  are  as  willing  as  they  are  ? 

Miss  MiTFORD.  I  disagree  with  whoever  said  it  was  done  for  patriotic 
motives  because  they  are  very,  very  poor.  They  are  not  permitted  to 
earn  a  decent  wage.  They  get  a  wage  of  $2  to  $10  a  month.  Just  by 
ordinary  necessity,  they  have  to.  / 

Senator  Kennedy.  Do  you  think  that  prisoners  participate  in  ex- 
periments that  they  otherwise  would  not  participate  in  if  they  were 
on  the  outside  ? 


808 

Miss  MiTFORD.  There  was  a  survey  that  I  read  about  this.  The  Survey 
was  about  malaria  tests,  specifically.  It  went  something  like  this :  Of 
the  prisoners  who  were  asked  whether  they  would  participate  for 
money,  44  percent  said  yes ;  of  people  outside  who  were  poor,  27  per- 
cent said  yes ;  of  higher  educated  people,  all  said  no. 

Senator  Kennedy.  It  is  the  less-educated  who  are  exploited? 

Miss  MiTFORD.  Yes.  This  is  something  which  comes  under  the  head- 
ing of  "alleged  treatment."  The  drug  prolixin  can  turn  a  person  into 
a  robot.  This  is  something  I  wish  this  committee  would  take  up. 

Senator  Kennedy.  Is  it  a  drug  to  calm  prisoners  down  ? 

Miss  MiTFORD.  I  will  give  you  some  examples :  Vacaville  is  a  priso7i 
where  persons  who  are  considered  to  be  psychiatrically  insane  are 
sent. 

A  couple  of  years  ago,  the  newspapers  discovered  that  a  drug  called 
anectine  was  being  given  to  unruly  prisoners.  Anectine  is  a  derivative 
of  curarinae — which  was  used  by  natives  for  their  poison  darts — and, 
when  given  in  massive  doses  to  prisoners,  it  stops  their  breathing  for 
up  to  2  minutes.  When  they  were  in  this  condition,  the  therapist  sits 
by  their  bed  and  scolds  them  and  tells  them  to  shape  up. 

Senator  Kennedy.  Mr.  Cowan,  you  referred  to  the  payment  by  some 
drug  companies  to  prison  officials  who  have  to  rule  on  the  safety  of 
these  drugs.  Is  that  occasional  or  exceptional  or  is  it  common  ? 

Mr.  Cowan.  We  can't  tell  how  widespread  this  is.  One  of  the  most 
disappointing  things  to  us  was  the  discovery  that  Food  and  Drug 
does  not  have  that  information.  We  found  that  something  of  this 
nature  did  happen  in  many,  if  not  most,  of  the  institutions  Ave  visited. 
The  payment  takes  many  kinds  of  forms.  In  the  malaria  project  in 
the  Kansas  City  Jail,  which  is  funded  by  the  United  States  Govern- 
ment, the  man  who  is  doing  the  testing  has  applied  for  patents  for  at 
least  one  of  the  drugs  developed  in  those  experiments.  So  the  conflict 
of  interest  and  abusive  treatment  in  these  situations  seems  to  be  per- 
vasive. 

Senator  Kennedy.  Couldn't  anybody  in  the  FDA  tell  you  where 
these  tests  were  taking  place  ? 

Ms.  Adams.  As  recently  as  yesterday  I  talked  with  Dr.  Alan  Lissock, 
the  man  in  charge  and  the  FDA  of  monitoring  drug  tests  at  prisons. 
He  told  me  that  the  tests  are  computerized  by  the  names  of  individual 
drug  investigators  and  not  by  the  institutions  where  the  drugs  are 
tested.  The  FDA  has  recently  begun  keeping  a  card  file  in  'which  drug 
tests  are  categorized  under  the  names  of  institutions.  However,  the 
file  is  not  complete,  and  Dr.  Lissock  did  not  know  whether  it  was  avail- 
able for  public  use. 

Miss  MiTFORD.  I  had  the  same  experience.  I  asked  the  FDA  to 
furnish  a  list  of  prisons  where  the  experiments  Avere  going  on.  The 
man  I  talked  to  said  it  might  be  confidential  information.  They  do  all 
work  in  top  secrecy. 

Senator  Kennedy.  There  is  no  place  you  can  go  to  get  the  list  of  ex- 
periments that  are  being  used  in  prisons,  is  there  ? 

Miss  MiTFORD.  They  say  they  Avon't  release  that  information.  They 
claim  it  is  confidential.  As  one  executiA^e  of  a  drug  company  told  me, 
the  Vice  President  of  Wyeth,  that  this  information  is  as  confidential 
as  the  nature  of  the  drug  because  they  find  out,  they  might  find  out 
through  a  pipeline  in  a  prison  Avhat  is  going  on. 


809 

Senator  Kennedy.  Aileen  and  Geoffrey  Cowan,  do  you  think  that 
the  NIH  guidelines  should  be  broadened  to  include  other  research 
programs  as  well  ? 

Mr.  Cowan.  It  is  my  impression  that  the  NIH  guidelines  can  only 
take  in  what  they  do.  The  FDA  takes  care  of  most  private  financed 
drug  tests  and  the  FDA  guidelines  for  regulations  in  this  regard 
specifically  incorporate  the  NIH  guidelines. 

I  think  we  would  feel  that  every  test,  and  particularly  the  tests 
which  are  conducted  in  institutions,  should  require  at  least  the  guide- 
lines that  NIH  has. 

The  problem,  however,  is  not  that  the  guidelines  are  not  in  existence. 
It  is  just  that  nobody  enforces  them  or  pays  attention  to  them.  Virtu- 
ally everything  that  we  are  going  to  hear  about  today  has  come  to 
the  attention  of  the  public  through  a  reporter  or  some  other  way,  but 
not  through  the  Government  agency  responsible  for  overseeing  it. 

Ms.  Adams.  May  I  address  myself  to  your  question  of  motivation? 

Senator  Kennedy.  Yes. 

Ms.  Adams.  According  to  the  Department  of  Justice's  Bureau  of 
Prisons,  the  typical  inmate  is  incarcerated  with  a  95%  chance  that  he 
needs  medical  care.  Often  participation  in  a  drug  test  offers  the  only 
opportunity  for  an  inmate  to  have  a  physical  examination  and  to 
receive  badly  needed  medical  treatment. 

Senator  Kennedy.  Thank  you,  very  much.  You  have  presented  very 
distressing,  but  well-documented  comments.  Thank  you  all,  very  much. 

I  hope  you  can  stay  with  us  this  morning. 

Dr.  Wolfe  is  here  from  the  Health  Research  Group. 

Dr.  Wolfe. 

STATEMENT   OF  SIDNEY   M.    WOLFE,    M.D.,    HEALTH   RESEARCH 

GROUP,  WASHINGTON,  D.C. 

Dr.  Wolfe.  Before  getting  into  the  remarks  that  I  have  prepared, 
I  would  like  to  make  a  few  remarks  on  the  topic  of  experimental  pro- 
cedures for  abortion. 

I  think  there  is  an  additional  factor  beyond  that  which  was  just 
mentioned,  namely  receiving  medical  care  as  a  reason  for  prisoners 
participating  in  experiments. 

In  Michigan,  for  example,  once  the  prisoner  has  agreed  to  partici- 
pate in  experiments,  there  is  a  transfer  to  another  facility  made 
in  terms  of  resulting  improvements  in  housing,  clothing,  and  food. 
These  accommodations  are  far  better  than  they  are  in  the  prison.  Thus, 
in  addition  to  access  to  medical  care,  the  general  welfare  is  also  better. 

In  May  1972,  20  women  were  "bused"  from  Chicago  to  Philadelphia 
to  receive  abortions  in  an  out-patient  clinic.  The  trip  was  necessitated 
by  a  restrictive  State  law  in  Illinois  which  forced  women  who  wanted 
an  abortion  to  travel  to  other  States  for  legal  abortion — if  they  had 
the  money — or  to  have  "illegal"  abortions  in  Illinois  if  they  were  poor. 
When  a  Chicago  clinic  which  had  been  doing  illegal  abortions  was 
closed  by  the  police,  these  20  women,  all  thought  to  be  between  three 
and  six  months  pregnant,  were  brought  to  Philadelphia  where  a  new 
experimental  medical  device  called  the  "super  coil"  was  to  be  used  to 
induce  the  abortions. 


810 

This  experimental  method  was  to  be  performed  in  a  private  clinic 
in  Philadelphia.  The  physical  facilities  of  the  clinic  consisted  of  a 
reception  area,  group  therapy  room,  two  offices,  an  examination  room 
witli  three  examining  tables,  a  recovery  room  and  a  laboratory.  One 
physician,  two  registered  nurses,  and  a  receptionist  comprised  the 
staff  of  the  clinic.  The  20  women  in  question  ariived  at  the  clinic  in 
Philadelphia  on  May  13th.  Present  in  addition  to  the  clinic  physician 
was  a  psychologist  who  originated  the  super  coil  method  and  a  physi- 
cian from  Los  Angeles  who  had  no  i^revious  experience  using  the  super 
coil.  The  clinic  physician  also  had  never  used  the  super  coil  before. 

Of  the  original  20  women  who  arrived  in  Philadelphia,  five  either 
had  spontaneous  abortions  prior  to  leaving  Chicago,  or  were  deter- 
mined on  physical  examination  to  be  12  weeks  pregnant  or  less,  and 
therefore  did  not  have  to  undergo  the  super  coil  method.  The  remaining 
15  women  all  underwent  the  super  coil  method. 

The  young  women  involved  were  primarily  young  and  black.  Of  the 
15  women  whose  abortions  were  included  by  the  super  coil  technique, 
nine  or  60  percent  had  complications  during  the  weekend.  Of  these, 
three  or  20  percent  of  the  total  experienced  major  complications. 

Senator  Kennedy.  Is  that  high  average  or  a  low  average  ? 

Dr.  Wolfe.  According  to  the  Center  for  Disease  Control  in  Atlanta 
which  did  an  examination  of  this  tragedy  after  it  occurred,  this  is 
approximately  twice  the  total  complications  expected  from  the  saline 
method  for  mid-trimester  abortions,  and  the  number  of  major  com- 
plications was  more  than  seven  times  the  number  expected  with  saline 
abortions. 

The  three  major  complications  can  be  simimarized  as  follows : 

1)  An  18-year  old,  single  black  woman  who  was  approximately 
17  weeks  pregnant  had  uncontrollable  bleeding  following  removal  of 
the  super  coil.  The  patient  went  into  shock  and  was  transferred  to  a 
general  hospital  where  doctors  administered  seven  units  of  blood  but 
were  unable  to  stop  the  bleeding.  Surgeons  performed  emergency  sui"- 
gery  which  resulted  in  a  total  abdominal  hysterectomy.  The  sui'gery 
had  revealed  extensive  lacerations  of  the  uterus. 

2)  The  second  case  involved  a  22-year  old  single,  black  woman  also 
in  her  17th  week  of  pregnancy,  who  was  hospitalized  after  returning 
to  Chicago  because  of  severe  abdominal  pain.  She  too  required  ab- 
dominal surgery. 

3)  The  third  case  involves  an  18-year  old  Mexican- American  woman 
who  was  15  weeks  pre^ant  and  who,  three  days  after  the  abortion, 
became  severely  anemic  and  iron  injections  and  oral  iron  were 
administered. 

That  this  is  human  experimentation  at  its  worst  will  not  be  dis- 
puted by  many.  Nor  can  it  be  reasonably  argued  that  the  women's 
status  as  "economic  prisoners"  makes  them  significantly  different  from 
those  prisoners  actually  in  jail  who  are  also  a  major  target  for  human 
experimentation. 

I  would  like  to  briefly  examine  several  features  of  this  case  which 
are  common  to  much  human  experimentation  : 

1)  Economic  status:  had  these  Avomen  been  well-off  financially,  they 
could  have  had  a  so-called  saline  abortion,  performed  in  a  hospital 
setting  which,  according  to  the  Center  for  Disease  Control  investiga- 
tors who  collected  data  on  this  case,  is  significantly  less  dangerous. 


811 

I  think  in  general  this  highlights  the  fact  that  as  long  as  we  have 
two  classes  of  health  care,  we  are  nurturing  human  experimentation 
for  those  who  otherwise  don't  have  health  care. 

2)  Untested  medical  devices:  despite  repeated  claims  for  its  safety 
made  by  its  inventor,  the  super  coil  has  never  been  properly  tested 
according  to  several  experts  in  the  abortion  field,  and  there  are  no 
published  reports  documenting  its  safety  in  the  medical  literature. 
According  to  one  gynecologist,  the  use  of  the  super  coil  is  "not  based 
on  sound  physiologic  principles."  In  brief,  the  procedure  involves 
introducing  into  the  pregnant  uterus  a  plastic  strip  about  13  inches 
long  and  shaped  like  a  shoelace.  Additional  strips  are  inserted,  one  at 
a  time,  until  the  patient  feels  discomfort.  In  the  case  of  the  women  in 
Philadelphia,  the  number  ranged  from  4  to  12. 

In  the  several  years  since  it  was  developed.  Dr.  Karman,  the  Los 
Angeles  psychologist  who  invented  the  device,  has  been  told  by  lead- 
ing abortion  experts  that  it  was  not  preferable  to  the  Saline  method. 
The  inventor's  enthusiasm — unaccompanied  by  scientific  data — has 
been  the  main  force  behind  its  use  in  this  country  and  in  Bangla-Desh 
where  it  was  also  used  on  an  unknown  number  of  women. 

Whether  the  "inventor"  is  a  pharmaceutical  manufacturer,  in  the 
case  of  drugs,  or  a  manufacturer  of  medical  devices — there  is  a  need 
for  careful  regulation  to  assure  that  the  product  is  safe  and  efficacious 
to  act  as  a  countervailing  force  against  the  enthusiasm  of  the  pro- 
ducer. 

Senator  Kennedy.  Do  you  mean  a  private  physician  in  this  country 
at  this  time  can  go  ahead  on  this  type  of  experimentation  without 
any  type  of  oversight  by  any  Government  agency  at  all  ? 

Dr.  Wolfe.  In  some  ways,  it  is  even  worse.  A  number  of  people 
discussed  at  an  earlier  session  of  these  hearings  what  the  situation 
was  for  unapproved  drugs.  In  this  case,  the  situation  is  Avorse  because 
in  the  absence  of  any  kind  of  reasonable  or  comprehensive  legislation 
regarding  medical  devices,  there  is  not  even  the  minimal  need  to 
require  informed  consent  and  the  like. 

Senator  Kennedy.  There  had  been  no  review  by  any  peer  group 
before  this? 

Dr.  Wolfe.  That  is  correct.  If  it  happens  on  a  voluntary  basis,  that 
is  all  well  and  good. 

In  this  case,  it  did  not  even  happen  at  all  as  far  as  Ave  can  tell.  There 
is  no  way  to  tell  on  how  many  women  the  super  coil  has  been  used, 
what  the  statistics  regarding  crucial  morbiaity  are,  and  the  like. 

Senator  Kennedy.  Do  you  think  we  ought  to  have  regulations  on 
the  use  of  medical  devices  in  this  country  ? 

Dr.  Wolfe.  Yes,  there  is  no  question  about  that.  I  am  sure  that 
Mr.  Hutt  would  also  agree.  This  year,  Ave  Avill  hopefully  see  the  en- 
actment of  such  legislation.  At  the  present  time,  unless  something 
that  is  used  for  human  purposes  can  be  categorized  a  drug,  it  is  not 
possible  to  really  exert  any  significant  control  over  medical  devices 
such  as  the  so-called  super  coil. 

Senator  Kennedy.  Would  organized  medicine  be  able  to  do  it  AA'ith- 
out  regulation? 

Dr.  Wolfe.  I  think  they  could  do  anything  they  Avant  Avithout  Fed- 
eral regulation.  The  question  is,  can  or  Avill  they.  If  you  ask  what 
physicians  have  done  in  terms  of  the  so-called  "unapproved  uses  of 


812 

approved  drugs,"  only  on  occasion,  has  voluntary  surveillance  worked. 
As  was  brought  out  a  couple  of  weeks  ago,  once  a  drug  is  approved 
for  one  purpose,  it  can  be  used  by  a  physician  for  other  purposes 
often  without  any  kind  of  requirement  for  surveillance. 

Physicians  could  have  done  those  experiments  under  the  same  guide- 
lines required  for  totally  unapproved  drugs,  but  the  fact  is  as  often 
as  not,  they  don't.  Voluntary  regulation  by  the  medical  profession 
or  pharmaceutical  companies  does  not  seem  to  work. 

For  drugs,  the  1938  and  1962  laws  empower  the  FDA  to  demand 
proof  of  safety  and  efficacy  before  marketing.  For  medical  devices,  we 
still  await  much-needed  legislation.  Absent  such  legislation,  medical 
devices  can  only  be  regulated  after  they  have  been  shown  to  cause 
harm.  No  pre-market  testing  for  safety  and  efficacy  is  required.  If 
Such  legislation  were  already  on  the  books — the  Dr.  Karmans  would 
have  much  more  trepidation  about  using  such  devices  to  experiment 
on  humans. 

3)  Informed  consent:  since  this  type  of  mid-trimester  abortion  is, 
at  best,  experimental — it  is  proper  to  inquire  about  the  degree  to 
which  women  were  informed  about  its  dangers  and  told  that  it  was 
experimental.  A  Center  for  Disease  Control  report,  dated  October  31, 
1972,  documented  for  the  first  time  in  considerable  detail  the  complica- 
tion of  super  coil  abortion.  Since  these  15  women  were  the  subjects 
of  that  study  and  in  light  of  Dr.  Karman's  "enthusiasm" — it  is  not 
likely  they  were  properly  informed  of  the  risks  or  of  the  fact  that  a 
saline  abortion  was  much  safer.  In  fact,  we  understand  they  were 
told  it  was  a  ncAv  procedure  which  was  relatively  safe. 

Whether  the  product  is  the  Morning-After  Pill,  or  the  mid-trimester 
super  coil — the  patient  must  be  fully  informed  as  to  the  benefits  and 
risks.  It  becomes  increasingly  clear  that  the  only  reliable  way  this  will 
occur  is  to  require  the  physician  or  other  health  professional  to  have 
patients  sign  an  informed  consent  sheet — specific  to  the  drug  or  device 
or  procedure — indicating  she  (he)  has  read  the  information  and  has 
made  a  fully-informed  choice  to  accept  the  therapy.  Such  require- 
ments, at  least  for  new  abortion  methods,  are  recommended  on  page  9 
of  the  Center  for  Disease  Control  report. 

4)  Quality  control:  about  two  years  ago,  the  Center  for  Disease 
Control,  part  of  HEW,  in  Atlanta,  initiated  a  revolutionary  program 
of  abortion  surveillance  and  began  inspecting  and  collecting  data  from 
many  abortion  clinics  throughout  the  United  States. 

In  addition,  the  CDC  investigators  have  studied  many  "outbreaks" 
of  complications  occurring  in  such  clinics  as  the  one  described  here. 
In  the  course  of  these  studies,  they  have  developed  a  methodology  for 
measuring  some  important  aspects  of  quality  in  abortion  clinics.  The 
training  of  those  performing  the  abortion,  the  physical  facilities, 
back-up  facilities,  complication  rate,  follow-up  are  but  a  few  of  the 
variables  examined. 

Now  that  the  methodology  is  developed,  and  continues  to  develop — 
now  that  there  %vill  be  a  dramatic  increase  in  the  number  of  abortion 
clinics  in  the  United  States — there  is  a  critical  and  immediate  need 
for  surveillance  at  a  local.  State,  or  whatever  level  is  best  to  ensure 
good  quality  of  care  for  women  undergoing  these  procedures. 

Aside  from  the  CDC  effort  and  some  surv^eillance  at  a  municipal 


813 

level — the  burden  is  presently  on  women,  individually  and  collectively 
to  perform  this  monitoring  function. 

The  Philadelphia  Women's  Health  Collective,  contacted  to  provide 
housing  last  May  for  the  women  from  Chicago,  vividly  described  this 
problem  in  a  paper  entitled,  "The  Philadelphia  Story :  Another  Ex- 
periment on  Women." 

I  quote  from  that  paper,  which  also  described  other  problems 
involving  women's  health  rights: 

None  of  us  had  ever  heard  of  the  super  coil  technique.  We  attempted  to  get 
reliable  information  on  its  safety  as  a  procedure  and  came  up  with  completely 
contradictory  results.  Although  we  were  being  asked  to  participate  in  the  ac- 
tivities of  the  weekend,  none  of  the  questions  we  raised  to  any  of  the  people  in- 
volved in  arranging  the  weekend  were  satisfactorily  answered  . . . 

During  the  weekend  the  women  in  the  Collective  felt  an  almost  overwhelming 
sense  of  powerlessness  to  effectively  intervene  or  change  anything  that  was  hap- 
pening. We  feel  that  we  learned  at  first  hand  the  acute  need  for  a  network  of 
information  on  abortion  procedures  and  those  who  perform  them.  Only  such  a 
network  accessable  to  women  all  over  the  country  can  alert  women  to  the  pos- 
sibility of  exploitation  and  medical  mispractice  in  the  abortion  business. 

They  further  went  on  to  describe  an  episode  where  a  television  crew 
came  down  to  film  the  procedures  that  were  going  on  without  asking 
the  women  involved.  This  was  apparently  done  to  promote  this  method. 

Unnecessary  surgery  and  irrational  drug-prescribing — aided  and 
abetted  by  improperly  tested  drugs  and  devices — make  much  of  the 
practise  of  medicine  a  variety  of  human  experimentation. 

That  the  first  nationwide  effort  to  regulate  doctors — instead  of  just 
drugs — is  in  the  area  of  abortion  is  somewhat  ironic.  If  the  concept 
of  quality  control  doesn't  extend  to  other  aspects  of  medical  thera- 
peutics— the  results  will  continue  to  be  tragic. 

Thank  you. 

Senator  Kennedy.  Thank  you  very  much,  Doctor.  Is  it  the  case  in 
the  United  States  at  the  present  time  that  an  individual  doctor  can  use 
an  experimental  device  based  solely  on  his  own  individual  judgment 
without  any  kind  of  review  by  his  peers  or  follow-up  clinical  work? 
Is  that  the  situation  that  we  have  at  the  present  time  ? 

Dr.  Wolfe.  To  my  knowledge,  that  is  correct.  On  the  subject  of  peer 
review,  one  might  ask  what  about  institutions  that  have  mechanism, 
for  peer  review  ?  Do  they  have  properly  functioning  peer  review  ?  In 
the  case  of  that  Philadelphia  group,  it  was  done  in  an  institution,  an 
institution  that  was  legal  and  was  largely  performing  first  trimester 
abortions  using  a  relatively  safe  method. 

Despite  the  fact  that  it  was  set  up  as  an  institution  and  there  were 
other  people  (peers)  working  there,  including  physicians,  there  does 
not  seem  to  be  any  proper  review  of  the  method  prior  to  its  use. 

The  procedure  was  simply  done.  People  from  the  clinic,  themselves, 
participated  even  though  they  had  never  done  this  procedure  be- 
fore. The  institutional  peer  review  methods  which  have  been  sug- 
gested by  the  FDA  as  a  means  for  "regulating"  human  experimenta- 
tion seem  to  have  broken  down  here.  There  are  countless  other  instances 
where  peer  review,  does  not  seem  to  work. 

I  think  that  one  defect  in  it  is  that  the  review  does  not  include  the 
victims.  Women  are  100  percent  correct  when  they  say  that  they 
should  be  included  in  some  of  the  institutional  review  processes. 

Senator  Kennedy.  Thank  you,  very  much.  Your  testimony  has  been 
very  helpful. 


814 

Our  next  witness  will  be  Dr.  Sencer,  the  acting  director  of  the 
Health  Services  and  Mental  Health  Administration.  He  is  the  di- 
rector of  the  Center  for  Device  Control. 

We  welcome  you,  Dr.  Sencer.  Do  you  want  to  introduce  your 
colleagues? 

STATEMENT  OF  DAVID  J.  SENCER,  M.D.,  ACTING  ADMINISTRATOR, 
HEALTH  SERVICES  AND  MENTAL  HEALTH  ADMINISTRATION, 
ACCOMPANIED  BY  JOHN  JENNINGS,  M.D.,  ASSOCIATE  COMMIS- 
SIONER FOR  MEDICAL  AFFAIRS,  FOOD  AND  DRUG  ADMINISTRA- 
TION; PETER  BARTON  HUTT,  ASSISTANT  GENERAL  COUNSEL 
FOR  FOOD  AND  DRUGS,  DEPARTMENT  OF  HEALTH,  EDUCATION, 
AND  WELFARE;  DAVID  M.  LINK,  DIRECTOR  OF  THE  OFFICE  OF 
MEDICAL  AFFAIRS,  FOOD  AND  DRUG  ADMINISTRATION;  JOHN 
ZAPP,  DEPUTY  ASSISTANT  SECRETARY  FOR  LEGISLATION 
(HEALTH),  DEPARTMENT  OF  HEALTH,  EDUCATION  AND 
WELFARE 

Dr.  Sencer.  I  have  with  me  Dr.  John  Jennings,  the  Associate  Com- 
missioner for  Medical  Affairs  of  the  Food  and  Drug  Administration. 
Also  here  is  Mr.  Peter  Barton  Hutt,  Assistant  General  Counsel  for 
Food  and  Drugs,  Department  of  Health,  Education  and  Welfare. 
At  the  end  is  Dr.  John  Zapp,  Deputy  Assistant  Secretary  for  Legis- 
lation (Health),  Department  of  Health,  Education  and  Welfare  and, 
Mr.  David  M.  Link,  Director  of  the  Office  of  Medical  Devices  of  the 
Food  and  Drug  Administration. 

I  have  a  statement  that  I  would  like  to  have  included  in  the  record. 

Senator  Kennedy.  It  shall  be  included  in  the  record  at  the  end  of 
your  testimony. 

Dr.  Sencer.  I  would  like  to  emphasize  two  things.  First,  in  regard 
to  what  Dr.  Wolfe  spoke  about,  I  think  the  episode  demonstrates  the 
need  in  this  country  to  have  a  strong  and  successful  family  planning 
program  available  to  all  women  who  wish  to  make  use  of  it. 

I  think  this  would  minimize  the  need  for  abortion  and  unwanted 
births  and,  therefore,  would  decrease  the  morbidity  such  as  in 
Philadelphia. 

Recognizing  the  new  Supreme  Court  decision,  which  indicates  to 
us  that  the  number  of  abortions  in  States  are  likely  to  increase,  we  are 
discussing  with  the  States  the  need  for  reporting  so  as  to  help  prevent 
whenever  possible,  incidents  such  as  the  Philadelphia  problem.  I  think 
it  is  only  through  surveillance  that  we  can  pick  up  and  prevent  such 
occurrences  which  lead  to  unneeded  morbidity.  I  would  be  pleased  to 
answer  any  questions  you  might  have. 

Senator  Kennedy.  I  am  troubled  by  one  of  your  statements.  You 
say  that  that  shows  that  what  we  need  is  more  distribution  of  family 
planning.  That  may  very  well  be  true  and  probably  is,  but  it  seems 
to  me  that  this  reflects  a  whole  quality  of  control  issue. 

Dr.  Sencer.  I  think  if  we  had  good  programs  throughout  the  coun- 
try, those  people  who  wished  to  space  their  children,  could  do  so. 

Senator  Kennedy.  I  think  I  asked  Dr.  Wolfe  whether  it  is  possible 
now  for  a  doctor  to  use  an  independent  device  without  any  type  of 
oversight.  His  answer  to  that  was  yes.  I  think  that  is  the  broader  kind 
of  issue  that  these  hearings  are  driving  at. 


815 

This  was  rather  a  dramatic  example.  Isn't  that  really  the  issue  or 
am  I  missing  the  boat  on  that  ? 

Dr.  Sexcer.  No,  I  don't  think  you  are  missing  the  boat. 
Senator  Kennedy.  Now  we  shall  hear  from  Dr.  Jennings. 

STATEMENT  OF  JOHN  JENNINGS,  M.D.,  ASSOCIATE  COMMISSIONER 
FOR  MEDICAL  AFFAIRS,  FOOD  AND  DRUG  ADMINISTRATION, 
PUBLIC  HEALTH  SERVICE,  DEPARTMENT  OF  HEALTH,  EDUCA- 
TION, AND  WELFARE 

Dr.  Jennings.  I  have  a  statement  that  addresses  itself  to  that  issue, 
which  I  can  read. 

Senator  Kennedy.  We  will  include  that  in  the  record  at  the  end 
of  your  testimony. 

Dr.  Jennings.  Basically,  our  regulatory  authority  is  applicable 
only  after  the  fact,  after  the  device  is  on  the  market. 

Senator  Kennedy.  What  good  is  that  ?  We  are  starting  out  as  friends 
on  this.  I  hope  you  understand  that. 

(Laughter) 

Senator  Kennedy.  Isn't  it  true  ?  What  good  is  that  ?  We  are  trying 
to  help  find  out  if  you  have  sufficient  authority.  If  you  do  not  have  a 
sufficient  authority,  there  is  no  sense  in  taking  a  bum  rap  for  it.  Then 
the  ball  is  back  in  our  court. 

What  we  are  trying  to  find  out  is  whether  you  have  the  kind  of 
authority  that  you  think  you  should  have  or  whether  in  this  panel  of 
people  you  have  here  you  can  only  look  at  it  after  the  harm  has  been 
done.  Whether  that  is  really  sufficient  and  whether  you  think  that  it 
is  advisable  that  we  establish  some  other  kind  of  criteria,  that  is  what 
we  need  to  know.  Because  if  that  is  so,  then  we  should  all  work  on  it. 

Dr.  Jennings.  I  think  we  are  all  in  agreement  that  our  current 
regulatory  authority  over  medical  devices  is  inadequate  for  present 
day  requirements. 

Senator  Kennedy.  In  what  respect  ? 

Dr.  Jennings.  We  do  have  a  piece  of  legislation  that  was  introduced 
in  the  last  session.  Dr.  Zapp  and  Mr.  Hutt  can  discuss  the  particulars 
of  that  legislation.  We  are  all  in  agreement  that  we  need  further 
authority. 

Senator  Kennedy.  Could  we  talk  about  the  problem  a  little  bit  more 
as  you  see  it  and  then  hear  from  Dr.  Zapp  on  what  the  legislative  limi- 
tations and  requirements  could  be  ?  Could  you  tell  us  about  the  problem 
that  you  have  ? 

Dr.  Jennings.  For  medical  devices,  there  is  no  requirement  for 
premarket  clearance  of  new  devices,  no  matter  liow  different  they 
may  be. 

Senator  Kennedy.  It  is  almost  any  device  that  is  under  the  label  of 
experimental  that  can  be  used  ? 

Dr.  Jennings.  That  is  right.  There  is  no  requirement  for  the  report- 
ing of  adverse  reactions  to  medical  devices.  There  are  no  provisions 
governing  the  investigational  use  of  devices. 

These  are  the  obvious  differences  between  our  regulatory  authority 
over  new  drugs  and  that  which  applies  to  devices. 

Senator  Kennedy.  We  heard  that  includes  Dr.  De  Bakey,  who  is 
one  of  the  great  surgeons  of  our  time  as  well  as  what  is  happening  with 


816 

the  super  coil.  As  you  view  it,  there  is  currently  no  legislative  responsi- 
bility for  oversight  in  this  area  or  enforcement  by  the  FDA  until  after 
something  has  happened  ? 

Dr.  Jennings.  That  is  right.  Our  authority  over  devices  is  based  on 
the  requirement  that  they  be  properly  labeled,  including  adequate 
directions  for  use.  If  we  determine,  after  a  device  is  marketed,  that 
is  not  properly  labeled,  that  is,  that  there  are  not,  or  cannot,  be  written 
directions  adequate  for  safe  use,  we  can  take  the  stand  that  it  is  mis- 
branded  in  that  sense. 

But  present  law  puts  the  burden  of  developing  the  case  against  a 
device  on  the  regulatory  agency,  rather  than  putting  the  burden  on  the 
developer  of  the  device  to  prove  that  his  device  is,  indeed,  safe  and 
effective. 

Senator  Kennedy.  I  see  where  you  have  the  responsibility  in  the 
experimental  drug  area  and  we  have  seen,  over  the  course  of  our  earlier 
hearings,  where  drugs  are  still  being  inappropriately  used  in  the  coun- 
try because  it  is  a  new  use  for  an  old  drug,  and  thus  readily  available. 
There  is  some  doubt  that  the  FDA  is  equipped  to  carry  out  new 
responsibilities. 

It  seems  that  you  are  over-stretched  at  the  time  and  whether  you 
could  handle  a  new  kind  of  responsibility  if  we  were  to  move  into  that 
area,  is  questionable.  Perhaps  we  should  hear  from  Dr.  Zapp  here. 

Dr.  Zapp.  In  1971,  the  Department  introduced  a  bill  that  would 
require  pre-market  scientific  review,  in  certain  cases  and  would  pro- 
vide for  standard  setting  and  require  reporting  of  adverse  reactions. 
It  would  also  permit  greater  access  to  the  manufacturers  records 
by  the  FDA. 

Obviously,  we  would  urge  both  bodies  of  Congress  to  hold  hear- 
ings on  this  particular  bill.  We  have  included  in  the  present  1974  budget 
money  and  additional  personnel  slots,  because  we  feel  that  the  FDA — 
as  you  characterized  it  a  minute  ago — would  need  additional  property 
and  personnel  for  responsibility  that  they  would  have  under  a  new 
medical  device  authority. 

Senator  Kennedy.  But  that  has  not  been  reintroduced.  Mr.  Hutt, 
did  you  wish  to  add  anything  to  that  ? 

Mr.  Hutt.  I  believe  that  adequately  covers  it,  Senator. 

Senator  Kennedy.  Dr.  Sencer,  about  your  ability  to  followup,  is 
this  a  very  unusual  kind  of  case?  Are  there  other  cases  like  this? 

Dr.  Sencer.  Through  the  Abortion  SurveiUance  Program,  we  have 
como  across  other  episodes  of  morbidity.  I  can  think  of  one  in  New 
York  City,  where  the  saline  method  tha^  Dr.  Wolfe  described  was 
beino-  used  and  improper  techniques  led  to  infections. 

^\  e  picked  this  up  by  having  a  network  of  surveillance  through  the 
States.  It  first  came  to  our  attention  from  the  State  of  Arkansas,  where 
a  young  women  had  traveled  to  New  York  for  an  abortion,  became 
ill  and  died  after  she  returned  to  Arkansas.  Fortunately,  there  have 
not  been  too  many. 

Senator  Kennedy.  With  new  legislation  in  this  area,  I  suppose 
there  would  be  a  requirement  for  various  significant  increases  in  man- 
power and  inspection  and  enforcement  of  legislation,  would  there 
not  ?  Have  you  given  some  thought  to  that  ? 


817 

We  have  seen  in  past  hearings  on  DES  in  cattle  the  difficulty  the  De- 
partment of  Agriculture  had  in  enforcing  that.  We  have  also  seen 
the  limitations  in  the  experimental  drug  area.  We  are  going  to  be 
talking  about  a  whole  new  area  here. 

I  suppose  there  would  be  a  requirement  for  substantial  increases  in 
manpower  ? 

Dr.  Zapp.  Yes,  they  have  both  been  provided  for  in  the  1974  budget. 

Senator  Kennedy.  Do  you  recall  the  figures  ? 

Dr.  Zapp.  I  would  assume  they  would  be  the  same  as  our  1973  original 
budget  request. 

Senator  Kennedy.  Is  the  use  of  the  super  coil  method  in  the  clinic 
under  those  conditions  a  justifiable  medical  technique  in  any  sense  of 
the  word  ? 

Dr.  Sencer.  No. 

Senator  Kennedy.  Is  use  of  the  super  coil  now  justified  under  any 
conditions  ? 

Dr.  Sencer.  I  would  think  thai  the  only  situation  in  which  the  super 
coil  would  be  justified  would  be  under  research  circumstances  with 
qualified  investigators  Av^ho  adequately  followed  the  guidelines  that  are 
set.  It  w^ould  have  to  be  viewed  as  an  experiment  and  the  circumstances 
around  it  should  be  such  that  we  could  guarantee  that  the  facilities 
were  adequate. 

Senator  Kennedy.  Do  you  know  of  any  such  research  now? 

Dr.  Sencer.  No,  sir.  I  don't  think  there  is,  now. 

Senator  Kennedy.  To  your  information,  it  is  still  being  used  as  a 
technique  ? 

Dr.  Sencer.  To  the  best  of  our  knowledge,  it  is  not  being  used. 

Senator  Kennedy.  Thank  you  very  mu(5i. 

Mr.Hutt? 

Mr.  HuTT.  Yes,  sir  ? 

Senator  Kennedy.  We  indicated  that  we  w;ere  going  to  inquire 
from  you  this  morning  about  medical  devices  like  the  super  coil.  There 
have  been  a  number  of  charges  by  the  previous  witnesses  about  the 
role  of  experimentation  with  prisoners. 

We  had  asked  Mr.  Weinberger  to  come  up  and  present  the  adminis- 
tration's position.  Would  you  like  to  respond  to  that  while  we  have 
3^ou  here  ? 

Mr.  HuTT.  We  were  not  prepared  to  go  into  that  in  any  detail. 

Senator  Kennedy.  The  record  ought  to  so  indicate. 

Mr.  HuTT.  Our  only  comment  would  be  that  we  do  require  consent 
to  use  any  procedures.  At  this  time,  we  take  the  position  that  there  is 
no  greater  coercion  in  the  use  of  prisoners  than  in,  for  example,  the 
use  of  subordinates  in  hospitals,  the  use  of  medical  students  or  other 
persons  who  may  have  their  own  personal  reasons  to  engage  or  to  not 
enarage  in  medical  experiments. 

We  are  perfectly  prepared  to  review  our  position  on  this  in  the  light 
of  what  goes  on  in  these  hearings. 

[The  prepared  statement  of  Dr.  Jennings  follow^s:] 


818 


STATEMENT 
BY 

JOHN  JENNINGS,  M.  D. 

ASSOCIATE  COMMISSIONER  FOR  MEDICAL  AFFAIRS 

FOOD  AND  DRUG  ADMINISTRATION 

PUBLIC  HEALTH  SERVICE 

DEPARTMENT  OF  HEALTH,  EDUCATION^  AND  WELFARE 

BEFORE 
THE 

SUBCOMMITTEE  ON  HEALTH 
SENATE  CCMIITTEE  ON  LABOR  AND  PUBLIC  WELFARE 

MARCH  7,  1973 


819 


Mr.  Chairman  and  Members  of  the  Subcommittee: 

We  are  pleased  to  appear  before  you  today  to  respond  to  your  request 
for  Information  on  the  extent  to  which  products  characterized  as 
medical  devices  can  be  regulated  under  existing  legislative  authority. 

At  the  present  time,  the  Food  and  Drug  Administration's  (FDA)  regulatory 
authority  over  medical  devices  is  applicable  only  after  the  product  has 
been  marketed.   There  is  no  requirement  for  premarket  clearance  of  a 
medical  device  as  there  is  In  the  case  of  new  drugs.   Also,  in  contrast 
to  the  regulation  of  new  drugs,  the  law  does  not,  with  respect  to 
medical  devices,  provide  for: 

-  reporting  of  adverse  reactions 

-  registration  of  device  manufacturers 

-  control  of  the  investigational  use  of  devices 

Once  a  device  is  marketed,  however,  FDA  can  institute  appropriate 
regulatory  action  if  we  are  capable  of  establishing  in  court  that 
the  product  is  dangerous  to  health  when  used  as  directed  or  is 
Improperly  labeled.   This  can  be  both  difficult  and  time-consuming. 

We  do  want  the  Committee  to  understand  that  FDA  is  exploring  other 
avenues  of  improving  the  regulation  of  medical  devices  under  existing 
legislation.   Our  primary  statutory  basis  for  such  actions  is  derived 
from  the  provision  which  deems  a  device  to  be  misbranded  unless  its 
labeling  bears  adequate  directions  for  use. 


820 


-  2  - 

Our  first  steps  are  toward  Increased  protection  with  regard  to  medical 
devices  used  for  investigational  purposes.   By  regulation,  we  plan  to 
require  that  the  labeling  specify  the  investigational  nature  of  the 
product  and  that  such  devices  should  only  be  used  by  certain  qualified 
practitioners.   The  labeling  will  also  require  that  investigational 
studies  should  be  subject  to  institutional  committee  review,  and  that 
the  device  should  be  used  only  after  informed  patient  consent  is 
obtained.   We  also  anticipate  the  establishment  of  certain  minimum 
performance  and  safety  standards  for  some  devices. 

Our  experience  with  lUD's  (intrauterine  devices)  may  help  to  illustrate 
how  we  are  exploring  the  extent  to  which  material  and  design  standards 
might  be  used  in  assuring  safe  use  of  these  devices.   Our  most  concerted 
effort  regarding  lUD's  at  the  present  time,  is  in  trying  to  determine 
what  constitutes  a  reasonable  degree  of  safety  for  an  lUD  or,  more 
accurately,  what  degree  of  risk  in  the  use  of  lUD's  is  clearly 
unwarranted  so  that  regulatory  action  can  be  taken.   (Parenthetically, 
it  should  be  noted  that  FDA  has  issued  a  policy  statement  that  lUD's 
incorporating  metals,  drugs  or  other  substances  which  may  react  with 
the  body  are  new  drugs  subject  to  new  drug  premarketing  review  for 
safety  and  effectiveness.   However,  to  date,  only  one  lUD  is  subject 
to  this  policy.) 


821 


-  3  - 

Clearly,  these  steps  are  not  the  total  answer.   As  you  know,  the 
Administration  submitted  legislation  to  the  previous  Congress  that 
would  require  premarket  scientific  review  for  certain  devices, 
authorize  standard  setting,  require  reporting  adverse  reactions, 
and  permit  greater  access  by  FDA  Inspectors  to  manufacturers' 
records.  That  bill  would  also  authorize  the  strict  control  of  the 
Investigational  use  of  devices. 

Medical  device  safety  legislation  will  again  be  submitted  to  Congress 
In  the  near  future,  and  we  urge  you  to  give  the  measure  prompt 
and  serious  consideration. 

Thank  you  very  much  Mr.  Chairman,  my  colleagues  and  I  will  now  be 
pleased  to  try  to  respond  to  any  questions  you  or  other  Members 
of  the  Subcommittee  may  have. 


93-999  O  -  73  -  pt.  3—3 


822 

Senator  Kennedy.  Our  next  witness  is  from  the  Prisoners'  Rights 
Council  of  Philadelphia,  Pennsylvania,  Allan  H.  Lawson.  He  is  with 
Charles  J.  Schoefer,  who  is  with  the  People's  Bail  Fund  of  Phila- 
delphia. Accompanying  them  is  Mr.  Leodus  Jones,  who  is  now  working 
in  the  area  of  prisoner  experimentation. 

We  are  extremely  interested  in  hearing  their  testimony. 

STATEMENT  OF  ALLAN  H.  LAWSON,  PRISONERS'  RIGHTS  COUNCIL, 
INC.,  PHILADELPHIA,  PA.,  ACCOMPANIED  BY  CHARLES  J. 
SCHOEFER,  PHILADELPHIA  PEOPLE'S  BAIL  FUND,  PHILADEL- 
PHIA, PA.,  AND  LEODUS  JONES,  COMMUNITY  ASSISTANCE  FOR 
PRISONERS,  PHILADELPHIA,  PA. 

Mr.  Lawson.  I  have  a  prepared  text  that  I  would  like  to  enter  into 
the  record. 

Senator  Kennedy.  It  will  be  included  in  the  record  at  the  end  of 
your  testimony. 

Mr.  Lawson.  I  am  Allan  Lawson,  Director  of  the  Prisoners'  Rights 
Council,  Inc.,  in  Philadelphia,  Pennsylvania.  I  spent  about  10  years 
in  the  penitentiaries  in  Pennsylvania.  With  me  here  today  from  Phila- 
delpliia  are  Leodus  Jones,  Representative  of  Community  Assistance 
for  Prisoners  and  Bud  Schoefer,  Executive  Director  of  the  Phila- 
delphia People's  Bail  Fund. 

We  appreciate  this  opportunity  to  present  our  findings  and  opinions 
regarding  medical  experimentation  on  prisoners. 

We  will  begin  this  statement  by  describing  the  context  within 
which  the  human  experimentation  takes  place  in  the  Philadelphia 
County  prisons.  As  of  February  28,  1973,  there  were  2,764  inmates  in 
our  county  prisons:  1,252  in  Holmesburg  Prison,  692  in  the  Detention 
Center,  and  820  in  the  House  of  Correction.  Of  this  total  population, 
2,338  were  detentioners ;  indigent  defendants  awaiting  trial  in  jail 
for  periods  ranging  up  to  at  least  two  and  a  lialf  years. 

Senator  Kennedy.  Let  me  understand  you,  if  I  can.  You  have  said 
that  84  percent  of  the  prison  population  not  awaiting  trial? 

Mr.  Lawson.  They  were  people  who  have  been  accused  of  crimes  and 
are  too  poor  to  make  bail  and  they  are  sitting  in  the  jails. 

Detentioners,  therefore,  represent  a  minimum  of  84.4  percent  of 
our  prison  population,  and  spend  an  average  of  at  least  nine  months 
in  pretrial  confinement.  We  believe  this  constitutes  the  Nation's  lead- 
ing de  facto  preventive  detention  program. 

Ironically,  two-thirds  of  our  detentioners  will  eventually  be  found 
not  guilty,  or  have  their  cases  dismissed  without,  of  course,  receiving 
any  subsequent  financial  compensation.  Tliey  await  their  dispositions 
ineligible  for  participation  in  rehabilitative  programs  such  as  work 
release,  stud}^  release,  furlough,  et  cetera,  because  without  a  finding 
of  guilt  a  prisoner  does  not  need  rehabilitation. 

Senator  Kennedy,  If  I  understand  the  situation,  they  can't  partic- 
ipate in  any  of  these  programs  and,  therefore,  they  can't  gain  any 
other  source  of  income ;  is  that  right  ? 

Mr.  Lawson.  That  is  correct. 

Senator  Kennedy.  Why  do  you  need  any  income  in  prison  ? 

Mr.  Lawson.  You  need  it  especially  when  you  are  first  arrested. 


823 

You  have  to  take  care  of  your  basic  necessities.  You  have  to  get  an 
attorney.  You  have  to  try  to  get  money  together  for  your  family. 
Usually  when  poor  guys  are  locked  up,  they  are  snatched  off  the  street. 
If  they  own  anything,  they  are  going  to  lose  it.  You  have  to  have 
money  to  protect  your  own  belongings. 

The  guys  in  prison  don't  have  the  money  to  make  their  bail.  They 
need  means  available  to  them  in  the  penitentiary  so  that  they  can  help 
themselves  to  survive.  That  is  what  they  haA'C  to  do. 

Senator  Kennedy.  Do  you  need  any  money  in  prison,  itself  ? 

Mr.  Lawson.  Yes,  you  need  toothpaste  and  toothbrush.  You  need 
facecloths  and  you  need  soap.  You  need  deodorant.  You  need  letter- 
writing  materials.  You  need  legal  attorneys.  You  need  money  to  try 
to  get  your  bail.  You  need  money  to  hire  an  attorney,  because  most 
guys  don't  believe  in  the  public  defender  system  in  our  prisons. 

Because  of  this  fact,  the  prison  commissaries  in  1971,  sold  $311,000 
worth  of  merchandise  and  made  $55,000  profit.  This  economic  situa- 
tion led  the  court  to  conclude  that  those  prisons  constituted  cruel  and 
unreasonable  treatment  for  everybody  who  was  in  there.  The  court, 
also  concluded  that,  "Substantially  the  only  way  in  which  a  prisoner 
can  earn  money  is  by  participation  in  the  medical  testing  program 
conducted  in  the  prisons  by  the  University  of  Pennsylvania  and  Ivy 
Research  Laboratory." 

These  degrading  conditions  which  require  the  trading  of  human 
bodies  for  money  make  any  claim  of  voluntary  participation  by  prison- 
ers in  human  experimentation  a  cruel  hoax. 

These  conditions  caused  one  of  us  to  participate  in  human  experi- 
mentation in  the  Philadelphia  County  Prisons,  and  all  three  of  us 
are  here  today  to  demand  that  it  be  stopped. 

Now  let's  examine  the  human  experimentation  that  has  occurred  in 
the  Philadelphia  County  Prisons.  For  more  than  the  last  15  years,  Dr. 
Albert  M.  Kligman,  a  member  of  the  Dermatology  Department  of 
the  University  of  Pennsylvania  School  of  Medicine,  has  been  conduct- 
ing experiments  on  our  prison  population.  The  research  has  been  done 
by  Ivy  Research  Laboratories,  Inc.,  a  private  profit-making  Penn- 
sylvania corporation  founded  by  Dr.  Kligman  who  is  its  president 
and  chief  experimenter. 

Through  Ivy  Research  several  thousand  experiments  have  been 
conducted  on  thousands  of  prisoners.  The  experimentation  has  been 
wide-ranging.  They  include  the  testing  of  many  new  drugs  and  cos- 
metics and  testing  of  new  applications  for  many  already  marketed 
drugs  and  cosmetics.  These  experiments  have  also  involved  the  crea- 
tion of  various  bacteriological,  viral  and  fungal  infections  and  skin 
conditions.  Most  of  this  work  has  been  done  for  private  industry, 
some  for  the  U.S.  Department  of  Defense  and  some  is  Dr.  Kligman's 
personal  brainstorming.  Following  are  examples  of  recent  experi- 
ments. 

In  1971,  a  staph  infections  study  was  published.  This  study  involved 
150  male  Philadelphia  County  Prison  volunteers  age  25  to  40,  most 
of  whom  were  black.  The  men  were  infected  with  a  staph  infection 
on  their  forearms.  The  study  reports  that  three  prisoners  became  ill. 
It  became  necessary  to  give  many  others  antibiotic  treatment,  especially 
those  from  whom  skin  biopsies  were  taken.  Finally,  the  study  reports 


824 

that  ".  .  .  on  the  whole,  the  discomfort  caused  by  the  lesions  was 
cheerfully  borne  by  the  volunteers." 

In  the  fall  of  1972,  a  study  on  baby  shampoo  was  conducted  in 
Holmesburg  Prison  by  Ivy  Research  for  Johnson  and  Johnson.  This 
test  involved  dropping  shampoo  into  the  eyes  of  20  prisoners  for  a 
24-hour  period.  The  experiment  reportedly  paid  $3  per  man. 

Senator  Kennedy.  Do  you  mean  what  they  are  getting  into  is  in- 
formed consent  waivers? 

Mr.  Lawson.  No. 

Senator  Kennedy.  They  don't  ? 

Mr.  Lawson.  You  have  informed  consent  waivers,  but  that,  to  most 
of  the  men  in  a  penitentiary,  is  like  reading  hieroglyphics. 

Senator  Kennedy.  Is  that  a  lot  of  money  to  a  prisoner? 

Mr.  Lawson.  Yes;  that  is  a  lot  of  money.  If  you  can  get  a  job  in  a 
penitentiary  and  you  haven't  been  convicted  of  a  crime,  the  highest 
going  wage  you  might  get  is  50  cents  a  day.  If  you  left  a  family  in 
the  street,  you  have  got  to  take  the  50  cents  a  day. 

In  another  case,  the  Board  of  Trustees  of  the  University  of  Penn- 
sylvania requested  that  an  on-going  "Experimental  Fungus  Infec- 
tions'' study  be  continued  for  another  year.  This  was  in  November, 
1972.  This  study  is  apparently  being  done  for  the  U.S.  Department  of 
the  Army.  This  study  involves  the  use  of  300  prisoners  for  three- 
month  periods  at  $25  to  $50  per  man.  The  men  will  be  infected  this 
year  with  Staph,  Fungus,  Pseudomonas  and  Ringworm  infections. 
The  study  reported  that  the  Pseudomonas  "may  cause  serious  and 
even  fatal  skin  infections." 

In  December,  1972,  a  study  of  human  sweat  was  begun  in  Holmes- 
burg Prison.  This  study  involves  70  male  prisoners  who,  in  rotation, 
get  sealed  in  a  heat  chamber,  caused  to  sweat,  and  then  have  the  sweat 
from  their  armpits  collected  on  filter  paper.  It  is  reported  that  these 
filter  papers  are  taken  to  the  women's  section  of  the  House  of  Correc- 
tion in  an  attempt  to  determine  if  there  is  a  connection  between  the 
male  scent  and  the  regulation  of  the  female  menstrual  cycle. 

This  test  was  never  done  because  the  women  had  contact  with  men 
and  the  results  of  the  test  would  have  been  invalid. 

In  recent  years,  Dr.  Kligman's  prison  operation  has  been  embroiled 
in  controversy  on  two  occasions.  In  the  summer  of  1966,  Dr.  Frances  O. 
Kelsey  of  the  Food  and  Drug  Administration,  discovered  errors  in 
Dr.  Kligman's  test  reports.  This  led  to  his  removal  from  the  FDA's 
approved  list  of  new  new  drug  experimenters. 

A  month  later,  he  was  reinstated  on  the  condition  that  he  more 
closely  supervise  subordinates  and  more  carefully  keep  records.  In 
1968,  the  District  Attorney  of  Philadelphia  determined  that  "the  Uni- 
versity of  Pennsylvania  and  a  private  concern  named  Ivy  Labora- 
tories   had  a  generally  disastrous  effect  on  the  operation  of  Holmes- 
burg Prison."  This  resulted  from  the  role  that  Dr.  Kligman's  operation 
played  in  prison  sexual  assaults.  Once  again  this  was  due  to  poor 
supervision  and  judgment.  Obviously  Ivy  Research  survived  these 
controversies. 

lentil  recently  Ivy  Research  has  not  submitted  its^experiments  for 
review  and  approval  before  they  took  place.  In  1971,  Dr.  Kligman 
arranged  for  Dr.  Rawnsley,  a  coJleague  at  tlie  I^niversity  of  Pennsyl- 
vania Medical  School  to  review  Ivy's  experiments.  Dr.  Rawnsley  has 


825 

received  at  least  partial  payment  from  the  Inmates  Welfare  Fund  for 
his  services  and  has  recently  created  a  five-member  Institutional  Re- 
view Committee  of  which  he  is  chairman  and  on  which  there  are  no 
inmates.  The  only  other  medical  specialist  committee  member  is  also 
a  colleague  of  and  co-author  with  Dr.  Kligman  at  the  University.  Since 
last  summer,  this  committee  has  considered  and  approved  approxi- 
mately 80  protocols  without  holding  any  meetings.  These  protocols 
that  are  circulated  by  mail  are  totally  inadequate  for  this  purpose. 

Because  of  the  economic  situation  previously  described,  prisoners 
are  easily  recruited  for  participation  in  Ivy's  human  experimentation 
projects.  Ivy  determines  that  they  are  in  good  health  by  a  check  of 
their  intake  physical  records.  These  examinations  are  generally  super- 
ficial and  sometimes  completely  falsified.  After  approval,  the  inmates 
are  asked  to  sign  a  voluntary  consent  and  financial  liability  waiver 
form.  This  procedure  is  usually  if  not  always  administered  by  either 
another  inmate  or  by  a  "free  world"  laboratory  technician.  As  a  result, 
the  prisoners  generally  do  not  know  the  nature  of  the  test  in  which  they 
are  participating. 

We  find  nothing  in  the  Federal  Food,  Drug  and  Cosmetic  Act  to 
protect  human  experimentation  subjects  by  making  experimenters  fi- 
nancially responsible.  Consequently,  we  urge  the  creation  of  a  legal 
remedy  which  will  bind  experimenters  such  as  Dr.  Kligman,  Ivy  Re- 
search, the  University  of  Pennsylvania  and  the  drug  and  cosmetic  in- 
dustry to  locate  all  prisoners  used  in  past  tests  and  to  give  them  a  fairer 
and  more  substantial  share  of  the  profits  gained  through  the  coercive 
use  of  their  bodies. 

Nor  does  the  Federal  Food,  Drug  and  Cosmetic  Act  make  the  ex- 
perimenters liable  for  anything  but  record  keeping  obligations. 

The  prohibited  acts  section  essentially  protects  property  rights.  Sec- 
tion 331  (j) ,  for  example,  prevents  human  subjects  and  members  of  re- 
view committees  from  learning  the  exact  nature  of  the  experimental 
drugs  that  the  subjects  are  being  given. 

This  information  is  a  so-called  trade  secret.  Because  of  this,  we 
recommend  the  Federal  Food  and  Drug  Administration  should  be 
brought  immediately  under  the  provisions  of  the  Administrative  Pro- 
cedure Act.  The  FDA,  review  committees,  fully  informed  consent  and 
the  highest  ethical  conduct  are  no  protection  if  unlucky  prisoners  suf- 
fer present  or  future  side  effects  and  receive  no  compensation. 

We  sincerely  believe  that  all  testing  should  be  stopped.  But  what 
will  happen  to  prisoners  forced  to  submit  to  human  experimentation 
just  so  they  can  get  money  for  basic  necessities,  bail,  lawyers  and  finan- 
cial support  for  their  families?  To  totally  stop  testing  would  cut  off 
the  only  present  means  of  survival  for  most  prisoners.  This  is  a  vicious, 
vicious  circle.  Are  there  no  "acceptable"  solutions  ? 

Senator  Kennedy.  Let  me  ask  you,  Leodus,  I  undei-stand  you  were 
involved  in  some  of  these  e^'psriments.  Could  you  tell  us  a  little  bit 
about  them  ? 

Mr.  Jones.  One  of  the  reasons  that  I  got  involved  in  the  county  test- 
ing was  the  fact  that  I  was  arrested  and  I  didn't  have  the  money  tO'  pay 
my  bail.  The  only  way  I  seen  that  I  was  able  to  raise  bail  money,  with 
the  understanding  that  I  was  to  be  incarcei'ated,  was  to  submit  to  medi- 
cal testing. 


826 

So,  I  had  to  consider  taking  a  chance  on  the  testing.  On  one  of  the 
tests,  I  was  told  it  was  penicillin.  The  individual  who  told  me  didn't 
know  whether  it  was  penicillin  or  not.  This  is  something  he  told  me 
to  <^et  around  being  questioned. 

1  laid  in  a  metabolic  ward  for  about  two  nights  after  taking  these 
pills.  What  they  were,  I  don't  know.  I  only  went  by  what  I  was  told. 
Fortunately,  I  survived  and  I  have  the  notice. 

Senator  Kennedy.  How  much  did  you  get  paid  for  this? 

Mr.  Jones.  I  believe  I  got  paid  about  $30,  if  that  much.  It  has  been 
undei-stood  that  a  lot  of  these  fees  isn't  exactly  the  amount  that  you 
ai'e  supposed  to  receive. 

We  continue  to  submit  to  these  for  vaiious  reasons,  also  it  is  some 
means  of  support  for  our  families. 

Senator  Kennedy.  Do  the  people  that  have  money  in  prisons,  ai*e 
they  able  to  control  their  environment?  Is  it  a  better  life  if  they  have 
money  in  prison  ? 

Mr.  Jones.  Yes. 

Senator  Kennedy.  In  what  way  ? 

Mr.  Jones.  People  who  have  money  in  prison  are  not  faced  with  the 
question  of  not  being  able  to  afford  something.  If  they  have  money  and 
they  remain  in  prison,  this  is  due  to  the  fact  that  they  don't  have 
enough  for  bail. 

As  far  as  writing  materials  or  books  they  might  want  and  other 
thhigs  that  a  prisoner  has  a  right  to  leceive,  they  are  not  allowed  to 
have  these  things — those  that  don't  have  money.  They  are  going  to 
find  a  lot  of  things  that  they  need,  basic  necessities. 

Senator  Kennedy.  What  do  they  use  money  for  if  it  is  not  for  buy- 
ing the  various  products,  the  toothpaste  and  toothbrushes?  Did  the 
guards  treat  you  differently  if  you  had  money  ? 

Mr.  Lawson.  Generally,  they  treat  you  differently.  I  think  in  most 
situations,  whether  it  is  in  a  penitentiaiy  or  in  the  sti*eet,  if  you  have 
money,  you  are  better  off. 

Senator  Kennedy.  Do  you  have  any  opportunity  after  you  get  in- 
volved in  these  experiments  to  get  out  of  them,  if  you  don't  like  it? 

Mr.  Jones.  You  can  s:top,  if  you  want  to. 

Senator  Kennedy.  I  suppose  it  is  difficult  after  you  have  taken  pills 
to  stop  ? 

Mr.  Jones.  Yes,  After  one  test,  men  were  just  released  with  these 
germs  on  their  arms  and  backs  and  legs  and  other  parts  of  their 
bodies.  They  don't  loiow  who  to  contact  after  their  release  if  they 
break  out  in  a  rash. 

I,  myself,  at  one  time  I  was  doing  a  test  and  I  was  told  it  was 
some  type  of  germ  from  India.  It  was  placed  on  my  arm  and  it  sat 
there  for  about  five  days.  Then  an  infection  set  in.  It  began  to  swell. 
The  infection  lasted  and,  when  I  was  released,  it  had  not  really 
healed.  Wliether  it  w^ill  effect  me  in  the  future,  I  don't  know. 

These  people  go  into  it  blind.  They  don't  know  nothing  about 
nothing.  Those  who  conduct  the  tests  don't  know  nothing  about 
nothing.  These  are  just  experiments. 

Mr.  Lawson.  When  I  first  went  to  the  prison,  at  the  prison  I  was 
at,  they  didn't  have  any  testing.  I  had  heard  rumors  about  that  and 
that  that  was  one  of  the  ways  to  get  money  when  you  were  in  prison. 
One  of  the  first  things  I  noticed  was  in  the  shower  rooms  was  guys 


827 

with  patches  all  over  their  arms.  When  I  asked,  I  found  these  were 
from  prison  testing. 

Mr.  Jones.  Besides  that,  a  lot  of  guys  sign  up  for  these  tests,  basi- 
cally, on  account  of  on  the  county  level,  they  don't  have  to  come  before 
the  parole  board  and  have  a  plan  to  be  completed  before  they  are 
eligible.  Either  they  are  released  right  from  the  prison,  which  means 
they  are  right  back  out  on  the  street. 

A  lot  of  them  don't  have  a  home  to  go  to.  They  don't  have  clothing. 
They  don't  know  where  their  next  meals  are  going  to  come  from. 

Mr.  Lawson.  One  of  the  things  that  makes  the  whole  situation 
complex  is  that  some  guys  get  some  positive  benefits  out  of  testing.  If 
they  are  there  long  enough,  it  gives  them  a  chance  to  save  money  so 
they  will  have  it  when  they  come  out  of  jail.  Most  of  the  time  when 
a  guy  comes  out  of  jail,  they  don't  have  no  money.  You  know  how 
serious  the  prejudice  is  against  previous  offenders.  When  you  come 
out  of  prison  and  you  don't  have  any  money,  you  are  in  bad  shape. 
You  have  to  get  money  the  best  way  you  know  how.  Sometimes  the 
only  way  you  know  how  is  something  that  is  illegal. 

I  have  seen  some  guys  who  have  been  able  to  get  themselves  to- 
gether when  they  come  out  because  they  have  a  little  money  and  there 
is  not  as  much  pressure  when  they  come  out  to  get  a  job.  The  guys 
care  what  they  are  getting  into,  but  they  are  more  concerned  about 
the  money. 

Senator  Kennedy.  A  lot  of  these  people  were  released  ?  Two-thirds 
of  the  detentioners  were  not  even  tried  ? 

Mr.  Lawson.  Yes. 

Senator  Kennedy.  What  were  the  general  kinds  of  health  condi- 
tions in  prisons? 

Mr.  Lawson.  The  three  prisons  that  we  are  talking  about,  in  these 
three  prisons,  it  is  a  three-prison  complex.  They  are  located  close 
together. 

In  Holmesburg  Prison,  it  is  usually  three  or  four  guys  jammed  in 
a  cell.  There  is  a  window  in  the  top  of  the  ceiling.  The  damp  air 
leaks  down.  You  catch  all  kinds  of  colds. 

When  I  was  in  there,  I  caught  a  cold.  I  had  to  have  suction  cups 
put  in  my  ears.  There  is  no  hot  water  when  you  go  in  there  in  the 
morning.  There  is  no  hot  water  in  the  cells.  The  courts  have  already 
ruled  that  it  constitutes  cruel  and  unusual  punishment  to  be  there.  No 
change  has  been  made,  because  the  case  is  on  appeal.  So,  in  the  mean- 
time, the  guys  still  have  to  get  money. 

Senator  Kennedy.  When  those  offers  for  experimental  drugs  come 
along,  they  must  sound  pretty  good  to  get  out  of  those  cells  and  be 
involved  in  one  of  these  experiments  ? 

Mr.  Lawson.  It  is  more  so  the  money  than  just  to  get  out  of  the 
cell.  Generally,  you  could  volunteer  for  an  hour's  work  around  the 
penitentiary  to  get  out  of  the  cell,  but  you  don't  get  paid  there.  The 
only  job  they  have  available  will  pay  you  50  cents. 

[The  prepared  statement  of  Mr.  Lawson  follows :] 


828 

The   United  States  Senate   Subcommittee   On  Health 


EXPERIMENTATION   ON  PRISONERS  IN 
THE   PHILADELPHIA   COUNTY  PRISONS 


Prepared  Text 


Allan  H,    Law son 
PRISONERS"    RIGHTS  COUNCIL,    INC 
Philadelphia,    Penna, 


Charles  J,    Schoefer 
PHILADELPHIA   PEOPLE'S  BAIL  FUND 
Philadelphia,    Penna. 

Leodus  Jones 

COMMUNITY  ASSISTANCE    FOR  PRISONERS 
Philadelphia,    Penna. 


829 


Senator  Kennedy,  members  of  the  subcommittee,  ladles 
and  gentlemen.  I  am  Allan  Lawson,  1  Director  of  the  Prisoners* 
Rights  Council,  Inc.,  In  Philadelphia,  Pennsylvania.  With 
me  here  today  from  Philadelphia  are-Leodus  Jones,  Representa- 
tive of  Community  Assistance  for  Prisoners  and  Bud  Schoefer, 
Executive  Director  of  the  Philadelphia  People's  Ball  Fund. 
We  appreciate  this  opportunity  to  present  our  findings  and 
opinions  regarding  medical  experimentation  on  prisoners,. 

We  v;lll  begin  this  statement  by  describing  the  context 
within  which  the  human  experimentation  takes  place  In  the 
Philadelphia  County  prisons.  As  of  February  28,  1973  there 
v/ere  2,76^  Inmates  In  our  county  prisons:  1252  In  Holmesburg 
Prison,  692  In  the  Detention  Center,  and  820  in  the  House  of 
Correction..   Of  this  total  population,  2,333  were  detentloners; 
Indigent  defendants  aviaiting  trial  in  Jail  for  periods  ranging 
up  to  at  least  two  and  a  half  years.  Detentloners,  therefore- 
represent  a  minimum  of  8^.^^  of  our  prison  population,  nad 
spend  an  avera^^  of  at  least  9  months  in  pretrial  confinement. 
V/9  believe  this  constitutes  the  nation's  leading  de  facto 
preventive  detention  program. 

Ironically,  two  thirds  of  our  detentloners  will  event- 
ually be  found  not  guilty,  or  have  their  cases  dismissed  with- 
out, of  course,  receiving  any  subsequent  financial  compensa- 
tion.. They  await  their  dispositions  ineligible  for  participa- 
ti en  in  rehabilitative  programs  such  as  work  release,  study 
release,  furlough,  etc.,  because  without  a  finding  of  guilt  a 

-1- 


830 


prisoner  does  not  need  rehabilitation*  Almost  all  wait  In  Idle- 
ness as  our  three  prisons  provide  enough  Jobs  to  occupy  only       ! 
about  1S%   of  the  total  population.   The  few  Jobs  that  exist  are 
generally  unskilled  and  i reserved  primarily  for  sentenced  prisoners. 
The  work  pays  no  more  than  $.50  per  day,  though  a  local  three- Judge, 
court  recently  found  In  ':   Jackson  vs.  Hendrelckg.  (Philadelphia 
Court  of  Common  Pleas,  April   1972) that  most  of  the  Jobs,  In  fact, 
paid  nothing.   This  lack  of  Jobs  and  the  prison's  failure  to  pro- 
vide basic  necessities  makes  the  prisoners'  need  for  money  acute. 
Koney  is  needed  to  purchase  such  necessities  from  the  commissary 
ns  towels,  soap,  wash  cloths,  toothpaste,  toothbrushes  deodorants-^- 
and  foods  to  supplement  and  substitute  in  starchy  diets.   Money 
is  rl.so  needed  for  writing  materials,  law  books," newspapers,  maga- 
zines, bail  deposits  and  attorney  fees.   In  this  connection,  the 
three  prison  commissaries  in  1971  sold  ;j^311  »000worth  of  merchandise 
n)nj  mnde  .'1^55.000  profit.   This  economic  situation  lead  the  Court 
to  conclude  that  " (S)ubstantially  the  only  way  in  which  a  prisoner 
crm  earn  money  is  by  participation  in  the  medical  testing  program 
conducted  in  the  prisons  by  The  University  of  Pennsylvania  and 
Ivy  Research  Laboratory."  These  degrading  conditions  which  require 
l.b'^  trndjnr  of  human  bodies  for  money  moke  any  claim  of  voluntary 
p'lj  I  I  ci  potion  by  prisoners  in  human  experimentation  a  cruel  hoax. 
TliosG  conditions  caused  one  of  us  to  participate  in  human 
experimentation  in  the  Philadelphia  County  Prisons,  and  all  three 
of  us  are  here  today  to  demand  that  it  be  stopped. 


-2- 


831 


Now  let's  examine   the  human  experimentation  that  has  occurred    ; 
in   the   Philadelphia  County  Prisons.      For  more   than  the   last   15 
yenrs.   Dr.    Albert   M,   Kllgman,    a  member  of  the  Dermatology 
Department   of  the   University   of  Pennsylvania  School   of  Medicine, 
has  been   conducting  experiments   on   our  prison  population.      The 
research  has  been  done   by  Ivy  Research  Laboratories,    Inc.,    a 
private   profit-making  Pennsylvania  corporation  founded  by  Dr.   Kllgman 
who   is   its   president   and   chief  experimenter. 

Through  Ivy  Research   several   thousand  experiments  have   been 
conducted    on  thousands   of  prisoners.      The   experimentation  has 
been  wide-ranging.      They   Include   the   testing  of  many  new  drugs 
ond   cosmetics  and   testing   of  new  applications   for  many  already  ! 

irnrketed  drugs  and   cosmetics.      These  experiments  have   also  Involved 
thc!   creation  of  various  bacteriological,   viral  and   fungal 
Infections  and   skin  conditions.      Most   of  this  work. has  been  done 
for   private   industry,    some   for  the  U.S.   Department   of  Defense   and 
c:oiMi    is  Dr.    Klipman's  personal  brainstorming.      Following  are 
ox.'Miiples   of   recent  experiments.  i 

In    1971   a   staph   infections   study  was   published.      This   study 
jiivol.vcid    150   mole   Philadelphia  County  Prison  volunteers   age 
'.'5   to  ^0,    most   of  v;hom  were,  black.      The   men  were   Infected  with 
f   staph   Infection   on  their  forearms.      The   study  reports  that 
three   prisoners  became   111.      It  became  necessary  to  give   many 
others  antibiotic  treatment,   especially  those   from  whom  skin 


-3- 


832 


biopsies  were  taken.  Finally,  the  study  reports  that  "....on  the' 
vjhole»  the  discomfort  caused  by  the  lesions  was  cheerfully  borne  ' 
by   the   volunteers." 

In  the    fall   of   1972,    a  study   on  baby   shampoo  was   conducted 
in  Holme sburg  Prison  by  Ivy  Research   for  Johnson  and   Johnson.      This 
test   involved  dropping   shampoo  into  the   eyes   of   20   prisoners   for 
a  2^-hour  period.      The   experiment   reportedly  paid  $3,00.    P©r  men. 

In  another  case,    the  Board   of  Trustees   of  the  University  of 
Pennsylvania  requested   that  an  on-going   "Experimental   Fungus 
Infections"    study  be   continued  for  another  year.      This  was   in 
Wovember,    1972.      This   study   is  apparently  being  done   for  the  U.S. 
Department   of  the  Army,      This   study   Involves   the  use    of   300 
prisoners   for  three   month   periods  at   $25.00   to  $50.00   per  man. 
The   men  will  be    Infected   this  year  with   Staph,    Fungus,    Pseud omonas 
nnd    Ringworm  infections.      The    study   reported   that   the   Pseudomonas 
"nvny   cause   serious  and  even  fatal   skin  Infections." 

In  December,    1972,    a   study   of  human   sweat  was  begun   in 
Ilolmcr;burfr  Prison,      This   study   involves  10  male   prisoners  who, 
in    rotntion,    get   sealed   in  a  heat   chamber,    caused   to   sweat, 
nnd    then  have    the    sweat   from  their  armpits   collected   on   filter 
t)r-pe2'.      It   is   reported   that   these   filter  papers   are   taken  to 
the   v;omen's   section   of   the  House    of  Correction   in  en  attempt 
to  determine   if   there   is   a   connection  between  the  male   scent 
nnd    the   regulation   of   the    female   menstrual   cycle. 

In   recent   years.    Dr.   Kligman's  prison   operation  has  been 
en'brolled    in   controversy   on   two   occasions.      In  the    summer   of 
1966,    Dr.    Frances   0.   Kelsey   of  the   Food   and  Drug  Administration, 


-if- 


833 


discovered   errors  In  Dr.   Kllgman's   test   reports.      This   lead  to 
his   removal   from  the   F.D.A.'s  approved    list   of  new  drug 
experimenters,      A  month   later  he  was  reinstated    on   the    condition 
that  he   more   closely   supervise    subordinates  and  more    carefully 
keep  records.      In   I968,    the  District  Attorney   of  Philadelphia 
determined    that    "the  University   of  Pennsylvania  and   a   private 
concern  named  Ivy  Laboratories    ,    ,    .    ,      had  a  generally 
disastrous  effect   on  the    operation   of  Holmesburg  Prison."     This 
resulted   from  the   role   that  Dr.    Kllgman's   operation  played   In 
prison   sexual  assaults.      Once   again  this  was  due   to  poor   supervision 
and    Judgment,      Obviously  Ivy  Research   survived   these    controversies. 

Until  recently  Ivy  Research  has  not   submitted  Its  experiments 
for  review   and   approval  before   they   took  place.      In   1971 i 
Dr.   Kligman  arranged   for  Dr.    Rawnsley,    a   colleague   at   the  University 
of  Pennsylvania  Medical  School  to  review  Ivy's  experiments. 
Dr.    Ivnvnsley  has  received  at  least  partial  payment  from  the  Inmates 
i/olfnre   Fund  for  his   services  and  has  recently  created  a 
flvo-member  Institutional   Review   Committee    of  which  he   is   chairman 
nnd    on  which   there   are  no  Inmates,      The    only   other  medical 
SDfsclallet   committee   member  is  also  a  colleague    of  and   co-author 
ni bh  Dr.    Kligman   at   the   University.      Since   last   summer,    this 
cojiiinlttee   has   considered  and   approved   approximately  80   protocols 
without   holding  any  meetings.      These   protocols   that   are   circulated 
by  riiall   are    totally   Inadequate    for  this   purpose. 

Because    of   the   economic   situation  previously  described, 
prisoners  are  easily  recruited  for  participation  in  Ivy's 


-5- 


834 


human  experimentation  projects.   Ivy  determines  that  they  are  in 
pood  health  by  a  check  of  their  intake  physical  records.   These 
examinations  are  generally  superficial  and  sometimes  completely 
falsified.   After  approval,  the  inmates  are  asked  to  sign  a 
voluntary  consent  and  financial  liability  waiver  form.   This 
procedure  is  usually  if  not  always  administered  by  either  another 
inmate  or  by  a  "free  world"  laboratory  technician.   As  a  result, 
the  prisoners  generally  do  not  know  the  nature  of  the  test  in 
v/hich  they  are  participating. 

We  find  nothing  in  the  Federal  Food,  Drug  and  Cosmetic  Act 
to  protect  human  experimentation  subjects  by  making  experimenters 
finnncially  responsible.   Consequently,  we  urge  the  creation  of 
a  lofral  remedy  which  will  bind  experimenters  such  as  Dr.  Kligmen, 
Ivy  Research,  the  University  of  Pennsylvania  and  the  drug  and 
cosmetic  industry  to  locate  all  prisoners  used  in  past  tests 
n/id  to  give  them  a  fairer  and  more  substantial  share  of  the 
uroflts  frained  through  the  coercive  use  of  their  bodies, 

1.1  or  does  the  Federal  Food,  Drug  and  Cosmetic  Act  make  the 
^•'I'o  rli-;er\tGrs  liable  for  anything  but  record  keeping  obligations, 
T'lo  prohibited  acts  section  essentially  protects  property  rights, 
i'-Maion  331  (J)t  for  example,  prevents  human  subjects  and  members 
of  rovlew  committees  from  learning  the  exact  nature  of  the 
cTDorimental  drugs  that  the  subjects  are  being  given.   This 
Information  is  a  so-called  "trade  secret."  Because  of  this,  we 
t'link  the  Federal  Food  and  Drug  Administration  should  be  brought 
immediately  under  the  provisions  of  the  Administrative  Procedure 


-6- 


835 


Act.   The  F.D.A.,  review  committees,  fully  Informed  consent 
and   the  highest  ethical  conduct  are  no  protection  If  unlucky 
prisoners  suffer  present  or  future  side  effects  and  receive  no 
compensation. 

We  sincerely  believe  that  all  testing  should  be  stopped. 
But  what  v;lll  happen  to  prisoners  forced  to  submit  to  human 
experimentation  just  so  they  can  get  money  for  basic  necessities, 
bail,  lawyers  and  financial  support  for  their  families?  To 
totally  stop  testing  would  cut  off  the  only  present  means  of 
survival  for  most  prisoners.   This  Is  a  vicious,  vicious  circle. 
Are  there  no  "acceptable"  solutions? 


836 

Senator  Kennedy.  Thank  you  very  much,  gentlemen. 

Our  next  panel  of  witnesses  is  Dr.  Bernard  Diamond  and  Alexander 
Capron.  Dr.  Diamond  is  a  psychiatrist  with  the  School  of  Criminology 
of  the  University  of  California.  Dr.  Capron  is  with  the  University 
of  Pennsylvania  School  of  Law  and  also  a  member  of  various  com- 
mittees, such  as  the  National  Research  (^ouncil,  particularly  the  Ad 
Hoc  Subcommittee  on  Ethics,  and  he  worked  on  the  preparation  of 
the  book,  "Experimentation  with  Human  Beings." 

We  welcome  you  to  the  committee. 

STATEMENT     OF     BERNARD     L.     DIAMOND,     M.D.,     SCHOOL     OF 
CRIMINOLOGY,  UNIVERSITY  OF  CALIFORNIA 

Dr.  Diamond.  Thank  you,  Mr.  Chairman. 

Senator  Kennedy.  You  have  some  testimony  here,  gentlemen.  Would 
you  like  to  summarize  that  and  we  will  insert  the  full  in  the  record. 
You  hit  the  high  points  on  it. 

Dr.  Diamond.  My  name  is  Bernard  L.  Diamond,  M.D.  I  am  a  psy- 
chiatrist and  professor  in  the  School  of  Law,  the  School  of  Criminol- 
ogy, and  the  Department  of  Psychiatry  of  the  University  of  Califor- 
nia, Berkeley  and  San  Francisco.  In  accordance  with  the  policies  and 
regulations  of  the  Department  of  Health,  Education  and  Welfare, 
the  University  of  California,  Berkeley,  requires  that  all  research, 
training,  and  demonstration  projects  and  all  other  activities  subject- 
ing human  subjects  to  risk  be  reviewed  by  a  committee  which  eval- 
uates the  risks  to  the  subjects,  the  ethical  issues  raised  by  the  use 
of  the  subjects,  the  efficacy  of  the  procedures  to  minimize  the  risks, 
and  the  adequacy  of  the  procedures  to  obtain  fully  informed  consent 
from  the  subjects. 

The  committee  is  also  charged  with  the  difficult  responsibility  of 
determining  whether  the  potential  benefits  of  the  research  are  com- 
mensurate with  the  risks  to  the  subjects.  The  committee  has  nearly 
absolute  authority  to  prohibit  or  require  modification  of  research  or 
other  activities  using  numan  subjects  which  do  not  meet  the  ethical 
and  legal  requirements  of  DHEW  and  the  university. 

I  have  been  chairman  of  that  committee  for  the  Berkeley  campus 
since  its  inception  in  1966,  and  I  have  reviewed  and  evaluated  sev- 
eral thousand  projects.  Although  the  DHEW  regulations  were  in- 
tended to  apply  only  to  projects  funded  by  that  department,  the 
University  of  California,  in  common  with  most  other  major  universi- 
ties, requires  that  DHEW,  or  higher,  standards  be  applied  to  all  proj- 
ects regardless  of  the  source  of  funding. 

I  am  also  chairman  of  the  Task  Force  on  the  Right  to  Treatment 
of  the  American  Psychiatric  Association.  This  task  force  has  the  re- 
sponsibility of  preparing  position  statements  on  the  rights  of  invol- 
untary patients  and  inmates  to  receive  medical  and  psychiatric  treat- 
ment appropriate  to  their  needs  as  well  as  their  right  to  refuse  such 
treatment. 

However,  I  do  not  speak  here  for  either  the  ITniversity  of  California 
or  the  American  Psychiatric  Association,  but  rather  as  an  individual 
who  has  had  considerable  experience  in  problems  of  crime,  delin- 
quency, forensic  psychiatry,  and  particularly  the  ethical  issues  in- 
volved in  research. 


837 

Within  many  prisons  and  to  a  lesser  extent  institutions  for  the 
mentally  ill  and  mentally  retarded,  biomedical  research  is  done  on  the 
inmates.  The  research  is  of  two  quite  different  types.  One  type  involves 
research  on  drugs,  serums,  vaccines,  and  other  substances  which  are 
applied  to,  injected  in,  or  ingested  by  the  inmates,  or  the  subjecting 
of  the  inmate  to  various  stressful  or  abnormal  environmental,  dietary, 
living,  or  working  conditions.  This  type  of  research  on  inmates  has 
nothing  whatsoever  to  do  with  the  inmates'  own  needs  or  with  the 
medical,  psychiatric,  or  criminological  conditions  which  were  respon- 
sible for  their  confinement.  The  subjects  are  used  in  these  experiments 
simply  as  human  guinea  pigs.  Prison  inmates  appear  particularly  at- 
tractive as  research  subjects  because  they  exist  in  a  highly  controlled 
environment,  stable  as  to  diet,  living  conditions,  and  location.  In  cer- 
tain types  of  research,  a  prison  offers  many  of  the  conveniences  of  the 
experimental  animal  populations  of  the  research  laboratory. 

The  inmate  guinea  pigs  are  caged  under  carefully  controlled  condi- 
tions, readily  available,  and  not  permitted  to  wander  away  on  their 
own.  The  inmates  are  ordinarily  paid  small  fees,  often  less  than  would 
be  the  expense  of  maintaining  expensive  laboratory  animals  such  as 
monkeys  and  chimpanzees.  Consent  of  the  inmate  to  act  as  research 
subject  is  usually  obtained,  but  whether  that  consent  is  a  freely  given, 
inf oiTned  consent  is  not  always  evident. 

The  other  type  of  research  involves  procedures  which  are  for  the 
purpose  of  investigating  supposed  causes  of  medical,  psychiatric,  psy- 
chological, or  criminological  abnormalities  believed  to  be  responsible 
for  the  inmates'  condition.  This  includes  research  into  the  causes  of 
conditions  such  as  schizophrenia,  mental  retardation,  sociopathic  be- 
havior, and  predisposition  to  violence  or  sexual  abnormality.  Al- 
though it  is  possible  that  the  individual  inmate-subject  might  be 
helped  by  the  fruits  of  such  research,  it  is  ordinarily  anticipated  by  the 
researcher  that  the  gains  are  long  range  and  will  benefit  a  similar  class 
of  persons  in  the  future,  rather  than  the  particular  subjects  partici- 
pating in  the  research.  This  difference  is  not  always  explicitly  under- 
stood by  the  subjects. 

Also  included  in  this  second  type  of  research  are  various  experi- 
mental treatment  procedures  which  are  intended  to  alleviate  abnormal 
conditions  of  the  inmate-subjects.  Such  therapeutic  procedures  are  ex- 
emplified by  psycho-surgery,  electroshock  treatment,  drug  and  chem- 
ical therapies,  and  a  wide  variety  of  pliysical  and  psychological  manip- 
ulative procedures.  Included  are  behavioral  modification  experi- 
ments and  the  so-called  token  economy  where  inmates  purchase  priv- 
ileges, and  sometimes  necessities,  with  tokens  received  for  desirable 
behavior. 

The  first  type  of  use  of  prisoners  as  experimental  subjects  has  been 
widespread  in  the  United  States  for  many  years.  However,  in  recent 
years  there  has  been  a  sharp  increase  in  the  use  of  experimental  pro- 
cedures of  the  second  type.  This  has  been  the  consequences  of  a  gen- 
eral increase  in  behavioral  science  research,  plus  a  growing  demand  by 
the  public  for  a  solution  to  the  rising  incidence  of  crime  and  violence. 
A  1972  survey  by  the  National  Institute  of  Mental  Health  of  mental 
health  and  correctional  institutions  for  adult  mentally  disordered 
oriminal  offenders  lists  19  "security"  hospitals,  23  mental  health  facili- 
ties, and  26  correctional  institutions  (68  institutions  in  all)  as  ha\  ing 


93-999  O  -  73  -  pt.  3—4 


838 

a    "comprehensive    treatment    program    for    mentally     disordered 

oii'enders." 

Because  few,  if  any,  treatment  programs  for  mentally  disordered 
criminal  offenders  have  achieved  the  status  of  demonstrated  success 
and  acceptance  by  the  scientific  community,  most  of  such  programs  are 
still  to  be  regarded  as  experimental,  and  it  is  proper  to  identify  all 
68  such  institutions  (together  with  an  unknown  number  of  others) 
as  engaged  in  research  and  experimentation  upon  their  inmates.  Such 
experimentation  may  involve  everything  from  very  low-risk  pro- 
cedures such  as  group  psychotherapy  to  high-risk  procedures  such  as 
brain  surgery. 

There  are  a  number  of  considerations  which  make  it  plain  that 
serious  ethical  and  moral  problems  arise  in  both  types  of  biomedical 
and  psychological  research.  These  are: 

1)  Such  research  and  experimental  programs  in  ''closed''  institutions 
serving  involuntarily  confined  inmates  have  very  low  visibility.  Neither 
the  public  nor  the  scientific  community  are  well-informed  as  to  what 
experiments  and  research  are  underway.  In  the  ordinary  research 
situation  of  the  university  or  research  institute,  specific  projects 
are  formulated,  the  methods,  procedures  and  goals  are  precisely 
defined;  application  is  made  to  a  Government  agency  or  a  private 
foundation ;  and  a  report  of  the  accomplished  research  is  made  to  the 
f  mi  ding  agency  and  also  to  the  scientific  community  through  publica- 
tion in  appropriate  journals.  Even  with  this  high  visibility,  serious 
ethical  and  moral  defects  in  the  experimental  procedures  may  arise. 
But  in  the  closed  institution  where  the  staff'  is  permitted  to  indis- 
criminately "try  out"  treatment  methods,  wholly  outrageous  experi- 
ments have  been  performed  w4iich  offend  against  moral  decency  and 
violate  the  most  elementary  principles  of  professional  responsibility. 

2)  Research  performed  in  many  institutions  for  the  mentally  dis- 
ordered offender  often  is  of  poor  quality,  with  inadequate  design  and 
methodology,  and  the  results  of  the  research  do  not  justify  the  risks 
to  tlie  subjects.  This  is  a  consequence  of  the  general  difficulty  in  ade- 
quately staffing  such  institutions  with  well-trained  personnel  and  their 
lack  of  affiliation  with  centers  of  high  quality  research,  such  as 
uni^'ersities. 

In  the  prisons  where  inmates  serve  as  guinea  pigs  for  the  testing  of 
neAv  drugs,  the  research  may  have  little,  if  any,  scientific  or  medical 
value.  Such  research  is  frankly  commercial,  and  is  solely  for  the  pur- 
pose of  allowing  pharmaceutical  companies  to  meet  Govei'nment  re- 
quirements for  the  introduction  of  new  drugs. 

3)  The  problem  of  informed  consent :  For  research  to  be  ethical  and 
responsible,  the  subjects  must  consent  of  their  own  free  choice  to  par- 
ticipate and  to  assume  the  risks  of  the  experiment ;  the  subjects  must 
be  mentally  competent  to  make  such  free  choice ;  they  must  not  be 
coerced,  intimidated,  or  unreasonably  persuaded  to  participate;  and 
they  must  be  fully  informed  (and  comprehending)  of  the  risks  they 
are  undertaking.  Rarely  are  these  minimal  conditions  of  informed  con- 
sent fulfilled  in  the  prison  or  other  closed  institution. 

It  might  well  be  claimed  that  no  inmate  who  is  involuntarily  con- 
fined in  an  institution  of  any  kind  is  sufficiently  free  of  coercive  pres- 
sures to  permit  his  free  consent  to  any  risk.  Boredom,  tedium,  and 


839 

illusory  hopes  of  special  benefits  may  badly  distort  an  inmate's  judg- 
ment even  in  the  absence  of  mental  disease.  Or  he  may  simply  be  so 
intimidated  and  so  dependent  upon  the  institutional  authority  that  he 
is  unable  to  refuse  what  is  made  to  appear  to  be  a  reasonable  request. 
Often  when  the  experiment  is  labeled  as  "treatment,"'  permission  of 
the  inmate  may  not  even  be  asked,  nor  will  he  be  informed  of  what  is 
going  to  take  place.  If  he  is  obstinate  and  refuses  to  allow  the  "treat- 
ment," he  may  suffer  the  drastic  consequences  afforded  to  uncoopera- 
tive, incorrigible  inmates. 

4)  Researchers,  in  general,  no  matter  what  their  training,  compe- 
tency, or  level  of  experience,  and  regardless  of  the  high  status  of  the 
institution  to  which  they  are  affiliated,  are  not  fully  to  be  relied  upon 
to  maintain  adequate  ethical  and  moral  responsibility  for  their  own 
research. 

Senator  Kennedy.  Why  not  ? 

Dr.  Diamond.  Few  of  them  are  malicious,  if  any,  and  none  of  them 
do  anything  intentionally,  but  they  are  so  close  to  their  work  that  they 
are  generally  deficient  in  terms  of  any  legal  responsibility  for  informed 
consent  and  there  very  creativity  and  their  ambition  for  sources  makes 
them  sometimes  oblivious  to  the  risk  of  the  subjects. 

In  our  view  of  many  hundreds  of  thousands  of  projects  at  the  uni- 
versity, a  large  percentage  of  them  have  some  kind  of  a  technical  defect 
in  the  informed  consent. 

The  University  of  California  at  Berkeley  does  not  permit  a  re- 
searcher, be  he  Nobel  prize  winner  or  director  of  a  world  famous  re- 
search laboratory,  to  be  the  sole  judge  of  the  ethical  issues  in  his  use  of 
human  subjects.  At  Berkeley,  as  at  most  major  universities,  whether 
the  researcher  be  graduate  student  or  distinguished  scientist,  he  still 
must  submit  his  research  proposal  to  a  review  committee  whose  mem- 
bers are  unconnected  with  his  department  and  who  are  specially  quali- 
fied to  evaluate  the  ethical  and  legal  aspects  of  his  experimentation 
upon  lumians. 

And  this  committee  can,  and  does,  require  modifications  of  the  re- 
search to  ensure  that  it  conforms  to  the  ethical  standards  subscribed 
to  by  the  university  and  by  the  scientific  discipline  to  which  the  re- 
search belongs. 

Yet,  today,  in  prisons,  "security"  hospitals  and  in  all  sorts  of  closed 
institutions  throughout  the  country,  research  and  experimental  proce- 
dures are  inflicted  upon  inmates  with  no  outside  review  and  the  im- 
position of  no  standards  or  controls  upon  the  researcher. 

The  qualifications  and  competency  of  the  researcher  may  never  be 
questioned,  and  there  may  never  be  the  slightest  inquiry  into  the 
ethical  and  moral  deficiencies  of  the  research  and  the  harm  which  is 
done  to  the  subjects. 

Tlie  present  DHEW  policies  on  the  protection  of  human  research 
subjects  were  initiated  in  1966  by  the  Surgeon  General  of  the  United 
States  Public  Health  Service.  Yet,  it  was  only  last  year  that  the 
Surgeon  General  became  aware  that  one  of  the  most  flagrant  viola- 
tions of  his  own  policy  existed  within  a  research  project  of  the  Public 
Health  Service :  that  is,  the  Tuskegee  syphilis  project.  Obviously,  no 
institution,  agency,  university,  hospital,  prison,  or  individual  is  above 
the  need  of  outside  surveillance  of  the  ethical,  moral  and  legal  aspects 
of  their  experimentation  on  human  beings.  Paradoxically,  those  in- 


840 

stitutions,  such  as  prisons,  which  are  most  in  need  of  such  surveillance, 
are  least  likely  to  receive  it  under  today's  conditions. 

Senator  Kennedy.  What  happens  in  the  prisons.  Doctor? 

Dr.  Diamond.  In  the  prisons,  there  is  no  control  whatsoever.  They 
often  set  up  double  committees  or  have  groups  that  are  intimately  in- 
volved in  the  running  of  a  prison  to  go  through  the  formality  of  ap- 
proving these  projects,  but  it  is  my  impression  that  the  boards  of  the 
prison  staff  take  none  of  the  kinds  of  responsibility  that  we  do  in  major 
universities  in  assuring  that  these  projects  are  ethically  proper. 

Senator  Kennedy.  Do  you  feel  there  should  be  some  kind  of  a  review 
committee  ? 

Dr.  Diamond.  Yes,  I  feel  there  must  be  some  kind  of  a  review  com- 
mittee, but  with  one  important  difference :  That  the  review  committee 
for  any  kind  of  closed  institution  should  be  composed  of  individuals 
entirely  outside  of  that  institution  and  having  no  relationship  to  the 
bureaucratic  structure  of  the  institution. 

Just  belonging  to  an  institution  may  corrupt  to  a  sufficient  degree. 
So,  house  committees  cannot  be  relied  upon  to  establish  adequate 
standards. 

Senator  Kennedy.  Should  the  NIH  guidelines  be  general  regula- 
tions ? 

Dr.  Diamond.  The  HEW  and  NIH  regulations  are  very  satisfactory. 
The  difficulty  is  that  they  are  not  enforced  in  such  institutions. 

The  policy  of  the  HEW  and  NIH  is  to  put  a  great  deal  of  respon- 
sibility on  the  major  institutions.  The  major  universities  have  ac- 
ce])ted  this  responsibility. 

Senator  Kennedy.  What  good  does  it  do  to  have  the  regulations 
if  they  are  not  enforced  ? 

Dr.  Diamond.  It  does  no  good  whatsoever.  It  might  do  a  great  deal 
of  harm  because  it  creates  the  misleading  impression  to  the  public  that 
something  is  being  done  for  the  situation  when,  in  fact,  nothing  is  being 
done. 

Senator  Kennedy.  It  is  your  testimony  that  you  don't  believe  they 
are  being  enforced  ? 

Dr.  Diamond.  I  believe  they  are  not  enforced  in  most  prisons  or 
institutions  that  are  not  formally  associated  with  large  universities. 

Particularly,  the  DFDA  has  been  very  lax  in  checking  up  and  find- 
ing out  whether  the  policies  are  adhered  to.  There  is  a  tendency  to 
take  the  word  of  the  researcher  and  that  is  it. 

Senator  Kennedy.  I  think  your  recommendations  include  some  of 
these  thoughts.  Would  you  summarize  your  thoughts  ? 

Dr.  Diamond.  I  would  summarize  that  by  pressing  on. 

The  following  are  my  recommendations : 

1)  That  all  prisons,  "security"  hospitals,  mental  health  facilities 
and  any  other  hospital,  institution,  or  correctional  facility  which  pur- 
ports to  do,  or  allow,  research,  treatment,  rehabilitation,  or  correction 
upon  involuntary  inmates  or  inmates  who  are  less  than  fully  competent 
to  give  informed  consent,  be  required,  as  a  minimum,  to  adhere  to  the 
principles 'and  policies  of  the  DHEW  as  set  forth  in  "The  Institutional 
Guide  to  DHEW  Policy  on  Protection  of  Human  Subjects.'' 

2)  That  such  regulations  and  policies  apply  to  all  treatment,  reha- 
bilitation, correctional  programs,  as  well  as  those  which  are  frankly 
experimental  and  of  a  research  nature.  This  is  necessary  because  of  the 


841 

demonstrated  lack  of  ability  of  such  institutions  to  clearly  distinguish 
research  and  experiment  from  accepted  professional  practice. 

3)  That  all  such  programs  be  reviewed  by  a  competent  committee 
which  is  given  the  authority  to  prohibit  or  require  the  modification 
of  the  program.  The  committee  should  be  composed  of  scientific  and 
medical  experts  together  with  other  persons  competent  to  judge  the 
ethical,  moral,  and  legal  implications  of  the  program.  To  ensure  high 
visibility,  the  committee  should  also  contain  members  who  represent 
the  general  public  as  well  as  minority  groups  and  the  inmate 
population. 

The  review  committee  must  have  actual  authority  and  not  just  func- 
tion in  an  advisory  capacity.  The  committee  must  be  prepared  to  enlist 
the  authority  of  the  courts  through  injunctive  and  other  legal  proceed- 
ings to  enforce  its  decisions.  It  must  be  free,  at  all  times,  of  political 
influence.  To  ensure  such  independent  authority  it  is  essential  that  the 
review  committee  be  entirely  outside  of  the  bureaucratic  structure  of 
the  institution  it  serves. 

Senator  Kennedy.  Very  fine,  Dr.  Diamond. 

We  heard  some  testimony  two  weeks  ago  about  the  psycho-surgery 
in  this  country — best  estimates,  anywhere  from  600  to  900  practices  a 
year.  Is  there  any  psycho-surgery  taking  place  in  the  prisons  today  ? 
Dr.  Diamond.  There  have  been  reports  of  various  preliminary  ex- 
periments with  psycho-surgery.  We  know  for  sure  that  at  the  Califor- 
nia Medical  Facility,  Vacaville,  there  were  at  least  three  cases  of  psy- 
cho-surgery. The  staff  of  the  hospital  enlisted  the  services  of  an  Air 
Force  surgeon  stationed  at  a  near-by  airbase  and  this  Air  Force  Sur- 
geon performed  psycho-surgery  on  three  prison  inmates,  presumably 
with  the  inmates  consent. 

Following  this,  they  sent  a  letter  of  intent  to  apply  to  the  California 
Counsel  for  Criminal  Justice  to  engage  in  research  to  do  more  psycho- 
surgery. There  was  so  much  bad  publicity,  that  they  withdrew  the 
letter  of  intent. 

There  has  been  no  further  psycho-surgery,  to  my  knowledge.  A 
recent  proposal  was  made  by  the  California  State  Health  and  Welfare 
Department  to  UCLA  in  which  they  are  going  to  engage  in  large 
research  studies  on  violence.  It  included  psycho-surgery.  Whether 
it  will  be  done  on  prisoners  or  not,  I  have  no  specific  knowledge. 
Senator  Kennedy.  How  much  in  behavioral  control  ? 
Dr.  Diamond.  There  is  a  great  deal  of  behavioral  research  going 
on.  Rarely  are  these  labeled  as  research.  Many  of  them  are  inadequately 
designed  and  not  properly  controlled.  They  all  have  high  potential 
for  abuse  to  the  inmates. 

Senator  Kennedy.  During  the  course  of  these  hearings,  we  have 
heard  that  those  who  have  borne  the  principle  brunt  of  research — 
whether  it  is  drugs  or  even  experimental  surgery — have  been  the 
more  disadvantaged  people  within  our  society ;  have  been  the  institu- 
tionalized, the  poor  and  minority  members. 

What  is  your  view  about  this?  Obviously,  the  society  generally 
benefits  from  the  work  that  is  being  done,  the  research  in  the  biomedical 
field  and  the  successes,  but  the  risks  are  not  generally  shared.  Is  this 
real,  actually,  or  is  my  impression  accurate?  Is  this  something  that 
as  a  society  we  ought  to  be  concerned  about  ? 


842 

Dr.  Diamond.  Yes,  sir.  I  am  most  concerned  about  such  procedures. 
Your  point  is  tremendously  well-taken,  that  the  majority  of  research — 
whether  it  be  psycho-surgery  or  experimentation  with  new  drugs — 
are  done  on  precisely  those  individuals  who  have  least  to  say  about 
their  own  destiny,  who  are  less  educated,  and  who  are  least  likely  to 
have  much  understanding  of  what  is  going  on.  They  tend  to  be  de- 
pendent individuals  who  lack  the  ability  or  who  are  not  in  a  position, 
to  protest  and  complain. 

When  things  go  wrong,  they  have  no  access  to  legal  services.  They 
are  not  the  kind  of  people  to  bring  malpractice  suits.  They  do  not  have 
legal  help  to  enable  them  to  remedy  the  wrongs. 

Their  socio-economic  situation:  their  lack  of  education  and  their 
status  in  many  institutions  which  makes  them  peculiarly  available  for 
this  kind  of  research  also  makes  this  research  and  these  procedures 
ethically  improper. 

It  is  my  opinion  that  no  individual  of  this  kind  is  really  able  to  give 
properly  informed  consent  to  these  kinds  of  experiments. 

Senator  Kennedy.  Should  we  permit  any  experiments  in  prisons 
at  all? 

Dr.  Diamond.  This  is  a  difficult  situation.  I  would  say  that  under 
the  present  circumstances,  with  the  inadequacy  of  control  and  the 
demonstrated  failure  of  the  Government  to  properly  make  certain 
that  ethical  responsibilities  are  met,  that  in  view  of  this,  all  experi- 
mentation should  be  prohibited. 

If,  on  the  other  hand,  it  could  be  demonstrated  that  adequate  rules 
could  be  designed  and  review  committees  actually  enforced  and  proper 
surveillance  maintained,  then  it  might  be  possible  under  such  circum- 
stances to  permit  such  research  to  go  on. 

Senator  Kennedy.  You  mentioned  in  your  testimony  that  out- 
rageous experiments  have  been  performed.  Do  you  want  to  give  any 
examples  of  that? 

Dr.  Diamond.  I  believe  the  psychosurgery  has  been  outrageous. 
I  tliink  the  anectine  experiments  which  were  done  at  the  California 
medical  facility  and  also  by  the  State  De]Dartment  of  Mental  Hygiene 
at  Atascadera  State  Hospital  could  be  included  as  outrageous 
experiments. 

I  think  there  have  been  so-called  token  economy  experiments  in 
which  the  patients  are  required  to  purchase  not  only  privileges  such 
as  canteen  privileges,  but  are  actually  required  to  buy  with  the  tokens 
the  right  to  sleep  in  their  bed  at  night  and  the  right  to  eat  their  food, 
as  pait  of  the  conditioning  program  for  such  individuals. 

I  think  these  are  outrageous.  There  have  been  programs  that  have 
used  drugs  such  as  apomorphine  which,  when  injected  into  an  individ- 
ual causes  profound  nausea  and  vomiting.  These  have  been  used  as  a 
form  of  behavior  modification  experiments. 

There  have  been  uses  of  electro-shock  therapy  for  the  purposes  of 
behavioral  control.  Although  it  is  labeled  as  treatment,  it  can  be  a 
means  of  punishing  such  an  individual. 

California  has  been  disgraced  by  the  fact  that  a  number  of  yeai'S 
ago,  before  capital  punishment  was  abolislied,  that  in  at  least  one 
case  in  San  Quentin,  electro-shock  ther'apy  was  administere<:l  to  a 
prisoner  in  death  row,  who  had  gone  into  a  psychotic  stupor.  He  was 
brought  out  of  this  stupor  with  electro-shock  therapy  foi'  the  purpose 


843 

of  gasing  him  because  State  law  does  not  permit  you  to  execute  an 
unconscious  prisoner. 
Senator  Kennedy.  Thank  you,  Dr.  Diamond.  Dr.  Capron? 

STATEMENT  OF  ALEXANDER  MORGAN  CAPRON,  M.D.,  ASSISTANT 
PROFESSOR  OF  LAW,  UNIVERSITY  OF  PENNSYLVANIA  LAW 
SCHOOL,  PHILADELPHIA,  PA. 

Dr.  Capron.  I  am  Dr.  Capron.  I  will  skip  over  part  of  my  statement. 

Senator  Kennedy.  Your  statement  will  be  included  in  full  in  the 
record  at  the  end  of  your  testimony. 

Dr.  Capron.  A  dozen  years  ago,  the  late  Edmond  Cahn  suggested 
that  the  limits  of  human  experimentation  "require  more  attention  and 
respect  than  lawyers,  ethicists  or  experimental  scientists  have  been 
given  them."  In  the  past  few  years,  the  concern  expressed  by  Cahn 
(among  others)  has  begun  to  be  met  as  many  scientific  and  lay  bodies — 
including  this  committee — have  cast  a  critical  eye  over  experimental 
practice  and  consequences.  I  do  not  share  the  view  of  the  researchers 
who  have  expressed  alarm  and  dismay  over  this  growing  scrutiny, 
especially  when  it  is  seen  as  unwarranted  intervention  by  "meddle- 
some intruders."  The  objective  of  the  "outsiders,"  like  that  of  the 
biomedical  scientists,  is  to  reduce  human  suffering — a  goal  which 
requires  not  only  the  advancement  of  knowledge  through  experimenta- 
tion but  also  the  protection  of  the  experimental  subjects. 

It  would  be  naive,  however,  to  suggest  that  even  full  adherence  to 
this  laudable  goal  will  mean  that  human  research  will  be  without  costs. 
Yet  it  is  precisely  for  this  reason  that  I  believe  that  the  organs  of 
government  must  play  an  active  role  in  formulating  policy  for  human 
experimentation  and  reviewing  its  consequences.  Researchers  defend 
their  work  by  pointing  to  the  benefits  they  may  turn  up  "for  society" 
when  they  "pursue  truth  and  knowledge,"  but  it  is  doubtful  that  they, 
even  with  review  by  professional  colleagues,  have  the  proper  capability 
or  authority  to  judge  all  the  societal  costs  and  benefits  of  the  means  or 
consequences  involved  in  their  research. 

It  is  not  only  appropriate  but  very  necessary  that  the  U.S.  Congress 
take  part  in  answering  the  fundamental  question:  "When  may  a 
society,  actively  or  by  acquiescence,  expose  some  of  its  members  to 
harm  in  order  to  seek  benefits  for  them,  for  others,  or  for  societv  as  a 
whole?" 

Nowhere  is  that  issue  more  starkly  posed  than  in  the  area  of  research 
with  prisoners,  on  which  I  have  been  asked  to  comment  this  morning. 
Tlie  special  urgency  of  this  scrutiny  arises  from  three  factors:  (1)  the 
subjects  involved  are  "captives"  of  the  State  and  are  only  available  for 
research  at  the  State's  sufferance;  (2)  their  peculiar  position  not  only 
renders  their  "consent"  to  participation  questionable  but  also  may  lead 
to  subtle,  and  often  unintended,  abuse  by  experimenters;  and  (3)  the 
research  is  carried  on  in  a  context  which  lacks  the  peer  influences  and 
controls  which  characterize  most  other  research  settings. 

It  is  particularly  appropriate  for  this  body  to  be  concerned  with 
prison  experimentation  since  the  level  of  that  research  can  be  ascribed 
in  larfi^e  measure  to  Federal  action  11  years  ago.  The  1962  Food,  Drug 
and  Cosmetic  Act  Amendm.ents  did  not  require  prison  testing,  of 
course,  and  it  does  not  appear  that  the  particular  problems  of  such 


844 

testing  were  foremost  in  the  minds  of  Senator  Kef auver  and  his  col- 
leagues when,  in  the  wake  of  the  thalidomide  tragedy,  they  drew  up 
legislation  to  reform  testing  procedures  and  requirements  for  new 
drugs.  But,  as  an  FDA  official  commented  recently,  Phase  I  drug  tests 
are  "ordinarily"  conducted  in  "normal,  institutionalized  adult  males" — 
that  is,  the  prisoners. 

I  don't  mean  to  suggest  that  the  only  important  experimentation 
with  prisoners  involves  investigational  drugs — as  you  are  already 
aware,  that  is  far  from  the  complete  story.  But  such  testing  repre- 
sents much,  and  probably  the  vast  majority,  of  prison  research.  (Exact 
figures  on  the  number  and  type  of  studies  conducted  in  American 
jails  and  prisons  do  not  exist,  so  only  a  rough  estimate  is  possible.) 

My  comments  on  the  need  for  a  thorough  rethinking  of  prison  re- 
search fall  into  parts — first,  a  broad  question  about  the  entire  enter- 
prise based  on  present  practices,  and  second,  a  number  of  particular 
suggestions. 

I  need  not  go  into  detail  about  examples  of  research  on  prisoners, 
about  which  you  already  know  a  great  deal.  A  quick  survey  of  the 
recent  literature  reveals  such  experiments  as:  1)  repeated  bilateral 
testicular  biopsies  and  injections  of  radioactive  thymidine  were  con- 
ducted with  Oregon  inmates  to  study  the  rate  of  spermatogenesis;  2) 
drug  testing  and  plasmapheresis  programs  in  half-a-dozen  institutions 
in  Oklahoma,  Arkasas  and  Alabama  left  what  was  described  as  a 
"trail"  of  infection,  illness  and  at  least  six  deaths  apparently  resulting 
from  the  program ;  3)  research  on  the  "aversive"  conditioning  effects  of 
a  drug  (anectine)  which  creates  muscle  paralysis  and  a  sensation  of 
suffocation  (like  drowning)  with  64  "extreme  acting-out  criminal  of- 
fenders" at  the  California  Medical  Facility,  including  five  who  were 
signed  up  by  the  institution's  Special  Treatment  Board  "against  their 
will"  and  another  18  who  indicated  that  "they  involuntarily  signed  the 
treatment  contract  (in)  that  they  felt  some  implied  pressure  to  do  so 
in  the  doctor's  request";  4)  the  use  of  Colorado  prisoners  as  organ 
donors,  a  practice  since  halted;  5)  the  artificial  creation  of  typhoid 
fever,  and  other  infections,  in  experiments  conducted  with  Federal 
funds  by  investigators  from  the  United  States  Army  and  the  Univer- 
sity of  Maryland ;  6)  research,  some  of  it  sponsored  by  the  Pentagon,  on 
treatment  for  artificially  induced  fungi  and  bacteria,  including 
Staphylcoccus  aureus,  Candida  albicans  and  Pseudomonas,  which 
could  cause  serious — even  fatal — infections;  7)  investigations  of 
d-amphetamine's  effects  on  menstruation  in  female  prisoners  at  the 
Federal  research  center  for  drug  abusers  and  addicts  in  Lexington, 
Kentucky ;  and  8)  the  experimental  induction  of  scurvy  in  11  prisoners 
in  Iowa,  two  of  whom  escaped  from  the  metabolic  ward  of  the  Uni- 
versity hospital  before  they  had  developed  such  clinical  signs  as: 
swollen  bleeding  gums,  perifollicular  hemorrhages  and  congested 
follicles,  joint  swelling  and  pain,  conjunctival  hemorrhages,  and 
bilateral  femoral  neuropathy. 

This  list  could  be  almost  endlessly  supplemented  from  the  medical 
literature,  particularly  with  drug  studies,  and  additional  examples 
are  to  be  found  in  the  popular  press,  such  as  Miss  Mitford's  recent 
Atlantic  article,  and  in  academic  works  such  as  the  casebook,  "Ex- 
perimentation with  Human  Beings,"  on  which  I  worked  with  Dr. 
Jay  Katz. 


845 

But  the  whole  story  is  not  told  by  concentrating  on  the  highly 
risky  or  painful  studies,  for  it  seems  to  me  just  as  troublesome  that 
a  huge  volume  of  mundane  and  scientifically  insignificant  experi- 
mentation is  being  done.  It  is  in  considering  the  combined  weight  of 
both  types  of  current  research  that  I  have  reached  the  conclusion 
that  a  prompt  and  complete  moratorium  should  be  called  on  prison 
research.  In  other  words  no  new  projects  should  be  approved  and 
wherever  possible  existing  studies  should  be  suspended  or  transferred 
to  a  nonprison  setting. 

I  do  not  make  such  a  far-reaching  proposal  lightly,  but  because 
it  seems  the  only  sure  way  to  accomplish  two  very  important  goals: 

First,  a  moratorium  is  the  only  way  really  to  shake  up  conven- 
tional, lockstep  thinking  on  the  use  of  prisoners  as  "guinea  pigs" 
and  to  "clear  the  decks"  of  existing  practices.  Only  if  we  go  back 
to  the  beginning  and  ask  ourselves  "Is  this  really  necessary  ?  Is  this 
the  best  way?",  will  we  get  a  true  perspective.  Otherwise,  each  new 
research  protocol  simply  seems  like  one  more  drop  in  a  very  large 
bucket. 

Second,  a  moratorium  would  provide  a  real  incentive  for  a  con- 
scientious attempt  to  reevaluate  the  conditions,  if  any,  under  which 
prison  research  seems  justified,  and  to  formulate  in  detail  legislative 
and  regulatory  safeguards.  At  the  same  time,  a  cessation  of  research 
would  provide  a  background  of  calm,  rather  than  crisis,  in  which  to 
reach  judgments.  Past  attempts  to  frame  guidelines  or  regulations 
have  largely  been  responses  to  tragedies :  the  Nuremberg  Code,  articu- 
lated in  the  judgment  passed  on  the  Nazi  doctors  by  our  military 
tribunal  after  the  war;  the  1962  drug  amendments,  adapted  in  the 
wake  of  the  thalidomide  disaster;  and  the  FDA's  "Institutional  Re- 
view Committee"  requirement,  proposed  by  Commissioner  Ley  in  1969, 
in  response  to  Congressional  criticism  following  revelations  of  abuses 
in  prison  drug  and  plasma  programs.  We  need  a  rethinking  of  prison 
research — and  we  certainly  ought  not  to  wait  for  another  tragedy  to 
provoke  it. 

Objections  can  certainly  be  raised  to  a  moratorium.  It  will  become 
more  difficult  and  expensive  to  conduct  many  studies,  and  some  im- 
portant studies  could  be  interfered  with — although  I  doubt  that  it 
would  be  too  difficult  to  get  nonpenal  volunteers  for  any  truly  im- 
portant, pressing  research.  The  penal  system  will  also  be  temporarily 
deprived  of  whatever  financial  and  social  benefits  research  programs 
provide.  It  is  doubtful  that  these  are  central  to  the  operation  of  the 
system — and  if  resources  from  such  extraneous  private  activities  did 
turn  out  to  be  of  central  importance  to  prisons,  then  that  in  itself 
would  suggest  a  major  problem  with  present  arrangements. 

The  denial  to  prisoners  of  the  opportunity  to  participate  in  research 
may  also  smack  of  "paternalism,"  but  I  believe  that  is  inaccurate. 
I  do  not  know  whether  most  prisoners  would  support  or  oppose  the 
moratorium,  and  I  do  not  believe  that  is  the  proper  question.  The 
real  concern  is  that  we  do  what  is  right  for  society — which  includes 
not  only  the  avoidance  of  exploitation  and  harm  to  prisoners  but 
also  a  proper  regard  for  the  direct  and  indirect  costs  to  the  State. 

In  many  countries,  including  Great  Britain,  medical  research  gets 
along  without  using  prisoners.  That  was  the  position  taken  in  the 
World  Medical  Association's  Draft  Code  of  Ethics  on  Human  Ex- 


846 

perimentation,  although  that  was  watered  down  in  the  WMA's  Dec- 
laration of  Helsinki  as  adopted  to  refer  to  subjects  being  "in  such 
a  mental,  physical,  and  legal  state  as  to  be  able  to  exercise  fully  his 
power  to  consent." 

Such  a  provision,  reminiscent  of  the  consent  requirement  of  the 
Nuremberg  Code,  leaves  up  to  the  reader  whether  prisoners  as  a 
group  do,  or  do  not,  fulfill  this  criterion  of  being  "so  situated  as  to 
be  able  to  exercise  free  power  of  choice." 

There  seems  to  be  a  growing  awareness  that  prison  experimenta- 
tion raises  profound  problems.  This  makes  the  present  time  all  the 
more  auspicious  for  an  across-the-board  moratorium.  To  wait  for 
piecemeal  reconsideration  would  not  only  be  ineffective  but  probably 
also  harmful.  For  example,  in  Pennsylvania,  Correction  Commis- 
sioner Allyn  R.  Sielaff  announced  a  few  months  ago  that  he  was  end- 
ing research  in  the  State  prisons  because  of  his  concern  that  prisoners 
were  being  exploited.  Yet  research  in  the  county  prisons,  which  in- 
clude a  high  percentage  of  persons  awaiting  trial,  continues,  although 
these  institutions  are  overall  less  well-equipped  than  the  State 
facilities. 

DHEW  has  recently  selected  groups  of  consultants  to  review  consent 
in  a  number  of  experimental  contexts — including  research  with  pris- 
oners— and  it  would  seem  to  me  that  the  institution  of  a  moratorium 
would  be  an  indication  to  DHEW  that  it  should  broaden  its  inquiry 
and  proceed  in  earnest. 

I'd  like  now  to  comment  on  six  specific  points  which  are  examples 
of  problems  which  should  be  resolved  during  a  moratorium.  I  will  keep 
this  brief  and  rely  on  elaboration  in  my  prepared  statement. 

1.  TYPE   OF  RESEARCH 

Perhaps  the  first  question  which  a  moratorium  would  provoke 
would  be  whether  a  distinction  should  be  drawn  between  studies  em- 
ploying prisoners  as  "normal  volunteers"  and  those  which  are  experi- 
mental forms  of  "treatment,"  based  on  a  general  penolo.q-ical  obiective 
or  a  specific  psychiatric  or  behavioral  goal  for  the  individual  prisoner. 

Though  there  would  seem  to  be  more  justification,  in  terms  of  special 
need,  for  allowing  the  latter  to  resume,  it  would  appear  that  such  re- 
search involves  some  of  the  most  troublesome  types  of  interventions 
imaginable,  not  only  in  terms  of  psycho-surgery — on  which  you  have 
already  heard  a  good  deal — but  also  in  many  studies  on  pyschotropic 
and  behavior-modifying  drugs. 

Moreover,  any  analogy  to  the  distinction  between  "subjects"  and 
"patient-subjects"  raises  the  question  of  who  is  really  the  "patient" 
(in  terms  of  benefits)  in  such  situations — the  prisoner,  the  institution 
or  society  ?  As  mentioned  in  the  Anectine  study,  "consent"  was  given 
by  the  institution  for  five  of  the  "patients"  who  refused.  Even  more 
than  in  nontherapeutic  drug  research,  the  role  of  "patient-subject" 
seems  to  emphasize  the  "forced  options"  with  which  prisoners  have  to 
deal. 

2.  COMMITTEE   RE\T^EW 

Just  as  a  few  years  ago  an  ideal  of  the  clinical  investigator  ("in- 
telligent, informed,  conscientious,  compassionate,  responsible")  was 
held  out  as  the  talisman  of  safe  and  proper  human  research,  so  it  seems 


847 

today  that  review  by  a  committee  of  peers  and  intelligent  laymen  is 
conjured  up  as  the  magical  protection. 

Yet  the  one  is  as  certain  to  fail  as  the  other — because  medical  edu- 
cation is  not  adequate  to  produce  "ideal"  investigators  and  because  the 
regulatory  bodies  seem  unwilling  to  devote  the  necessary  ingenuity 
and  energy  to  coming  up  with  a  really  viable  and  productive  committee 
mechanism. 

A  number  of  matters  concerning  review  committees  need  to  be 
addressed,  including : 

First,  we  need  to  make  sure  that  existing  regulations  are  well- 
enforced.  To  give  only  one  example  of  noncompliance,  in  Pennsyl- 
vania of  the  eight  county  systems  in  which  I  know  research  to  be  tak- 
ing place,  serious  problems  appear  in  the  review  procedures  in  at  least 
four :  in  one,  the  Institutional  Review  Committee  required  by  the  FDA 
to  be  "multidisciplinary"  is  made  up  entirely  of  physicians;  in  an- 
other, the  principal  research  investigator  is  a  member  of  the  committee, 
in  clear  violation  of  FDA  regulations;  in  a  third,  the  committee  never 
meets  to  consider  protocols  but  acts  only  by  mail,  a  deficiency  which 
may  be  true  of  the  other  seven  counties  as  well ;  and  in  the  remaining 
county  no  institutional  review  committee  had  been  appointed  a  year- 
and-a-half  after  the  FDA  mandated  it. 

A  second  problem  concerns  what  is  expected  of  the  Committees.  Can 
they  do  a  good  job  without  a  substantial  investment  of  time?  It  may 
therefore  be  necessary  to  compensate  committee  members — although  it 
should  probably  not  be  done  as  it  is  in  Philadelphia  where  the  com- 
mittee members  receive  their  compensation  ($600-$!, 000  per  year)  di- 
rectly from  the  one  research  corporation  which  runs  all  current  prison 
projects. 

It  is  also  necessary  to  ask  what  function  we  expect  the  laymembers 
of  such  committees  to  serve.  I  am  dubious  of  their  ability  to  import 
"community  values"  into  committee  discisionmaking  on  an  ad  hoc 
basis,  but  I  am  even  more  skeptical  of  the  creation  of  a  new  group  of 
specialists  in  this  type  of  work  such  as  I  understand  Bernard  Barber 
to  have  suggested.  Long-term  membership  in  a  committee,  or  even  on 
its  staff,  would  seem  to  me  a  sure-fire  formula  for  unimaginative, 
routine  and  bureaucratic  handling  of  the  proposals.  I  doubt  that  the 
people  who  would  be  attracted  to  a  lifetime  of  "reviewing"  work  would 
really  do  the  job  we  would  want  anyway. 

Lay  or  "community"  thought  and  values  are  very  much  needed,  but 
they  will  have  a  more  significant  impact  if  they  go  into  the  formula- 
tion of  really  much  more  exact  standards  for  prison  research  in  the 
first  place.  Where  lay  imput  can  be  important  on  an  individual  case 
basis  is  in  going  over  and  improving  "informed  consent"  forms. 

This  could  well  come  in  the  form  of  a  "patient-subject"  or  "con- 
sumer" viewpoint  (as  expressed  by  prisoners).  In  addition  to  Com- 
mittee review  and  approval,  this  would  give  prospective  application  to 
the  "reasonable  man"  standard  for  judging  informed  consent  in  each 
case,  just  as  the  recent  cases  in  California  ^  and  the  District  of  Colum- 
bia 2  now  require  its  after-the-fact  application  according  to  the  new 
standard  for  jury  evaluations  of  informed  consent  adopted  in  those 
cases. 

1  Cohhs  V.  Grmt,  104  Cal.  Rptr.  505  (1972). 

a  Canterbury  v.  Spence,  4©9  F.  2d  772  (D.C.  Cir.  1972). 


848 

A  final  improvement  in  review  committee  procedures — which  like 
the  foregoing  seems  applicable  outside  the  range  of  penal  institu- 
tions— deserves  special  mention.  If  review  committees  are  to  progress 
and  make  better  judgments,  they  need  to  learn  from  more  than  their 
own  limited,  local  experience.  Yet  DHEW  has  done  nothing,  so  far  as 
I  know,  to  develop  communication  among  the  committees.  They  could 
probably  best  undertake  this  by  supporting  the  periodic  publication  of 
a  "Clinical  Investigations  Reporter"  established  on  an  independent 
basis  in  a  university. 

Through  the  resolution  of  "difficult  cases"  at  the  local  level  and  on 
up  the  line,  such  a  reporter  would  permit  the  committees  to  work  to- 
gether to  develop  a  "common  law"  indicating  the  limits  of  permissibil- 
ity on  various  parameters;  it  could  also  encourage  scholarly  commen- 
tary on  various  developments  in  the  field.  Rather  than,  or  in  addition 
to,  setting  up  more  high-level  committees  to  screen  protocols,  the  Con- 
gress could  do  well  to  encourage  or  require  DHEW  to  open  up  a  few 
windows  on  the  process  and  let  some  fresh  air  blow  through. 

3.   KINDS   or  INSTITUTIONS 

It  may  be  that  certain  categories  of  institutions  are  inappropriate 
places  for  human  research,  either  because  of  their  condition  or  their 
population  (pretrial  detainees  v.  convicts).  No  limits  of  this  sort  have 
yet  been  explored. 

4.   CONSENT 

Doubts  about  the  validity  of  prisoner  consent  lie  behind  much  of 
the  current  concern  about  research.  Without  rehashing  all  the  old 
issues.  I  would  like  to  mention  two.  First,  it  is  necessary  to  make  sure 
that  information  is  clearly  and  accurately  conveyed  by  someone  who  is 
laiowledgeable  enough  to  elaborate  and  answer  prisoner's'  questions. 
Is  it  appropriate,  as  is  now  the  practice  in  many  cases,  for  the  investi- 
gator to  leave  to  obtaining  of  consent  to  a  non-medical  subordinate? 

Second,  what  level  of  compensation  is  appropriate?  Drawing  the 
line  between  exploitation  (too  little  paid)  and  undue  influence  (too 
much  paid)  is  plainly  a  very  hard  task.  Would  it  be  useful  to  place 
restrictions  on  the  use  or  destination  of  funds  (within  institution 
versus  outside,  for  family  or  for  prisoner  after  discharge)  ?  While  this 
may  be  too  paternalistic,  it  might  permit  more  reasonable  amounts  to 
be  paid  without  leading  to  the  sort  of  homosexual  scandal  that  rocked 
the  research  project  at  the  Homesburg  Prison  in  Philadelphia  in  1968. 

5.    MONITORING   TESTS 

From  the  viewpoint  of  protecting  the  public  (through  accurate  test 
results)  as  well  as  the  prisoners,  the  present  system  of  monitoring  drug 
trials  leaves  a  good  deal  to  be  desired. 

A  committee  at  the  National  Academy  of  Sciences  on  which  I  served 
I'ecently  considered  (at  the  request  of  the  FDA)  the  question  of  the 
relatiA^e  responsibilities  of  drug  companies  and  the  FDA  for  assuring 
the  safety  and  validity  of  drug  studies.  A  difficult  question,  which  I 
regret  to  say  we  did  not  entirely  resolve,  is  whether  monitoring  of  in- 
vestigators should  be  left  entirely  to  the  drug  companies. 


Wo 

Looking  to  the  future,  we  did  foresee  the  possibility  of  some  Govern- 
mental organization  being  responsible  for  "active  monitoring."  I  agree 
with  that  view,  but  would  disagree  that  we  ought  necessarily  to  pre- 
serve the  status  quo  at  the  present,  and  it  would  seem  appropriate  for 
statute  to  make  clear  its  power  and  duty  to  monitor  drug  testing  regu- 
larly and  not  just  when  serious  problems  arise.  If  properly  handled  the 
increased  burden  of  this  monitoring  ( which  could  be  taxed  to  the  drug 
sponsors)  should  be  more  than  repaid  by  the  benefits  in  test  process 
and  results. 

G.    INDEMNIFICATION 

Many  experiments  still  contain  exculpatory  language  in  their  con- 
sent form  despite  clear  DHEW  policy  to  the  contrary,  based  on  Tunkl 
versus  Regents  of  University  of  California.  It  seems  to  me  that  we 
must  go  beyond  this,  in  prison  research  and  generally.  Tunkl  only  talks 
of  public  policy  against  waiver  of  the  rights  to  sue  for  medical  negli- 
gence. We  need  to  consider  a  program  of  insurance  for  the  subjects 
of  research  to  cover  all  consequences  of  their  participation,  including 
those  arising  unf  oreseeably  and  without  negligence ;  if  we  were  com- 
mitted to  this  policy  we  could  devise  Avays  to  overcome  the  difficulties  in 
distinguishing  sequelae  related  to  research  from  those  that  are 
unrelated. 

Senator  Kennedy.  What  about  the  rest  of  society?  Don't  we  need 
to  develop  new  drugs  to  respond  to  new  health  needs  ?  If  you  have  this 
moratorium,  aren't  you  going  to  close  out  the  opportunity  to  develop 
new  and  possibly  life-sa'\dng  drugs. 

Dr.  C APRON.  I  doubt  any  important  research  would  be  curtailed.  If 
it  were  known  during  the  moratorium,  the  scientists  could  go  to  the 
public,  to  persons  who  could  make  a  free  and  informed  choice  as  the 
Nuremberg  Code  says.  I  doubt  that  any  valuable  research  would  be 
stopped. 

Senator  Kennedy.  Your  point  is  that  if  it  is  of  benefit,  they  should 
be  able  to  do  it  with  the  people  ? 
Dr.  Capron.  Yes. 

Much  of  the  research  that  goes  on  now  is  not  significant  drug  test- 
ing. It  is  merely  the  use  of  prisoners  the  way  you  would  use  a  tissue 
culture  or  something  in  a  laboratory.  Out  in  the  Philadelphia  prisons, 
most  of  the  research  that  goes  on  there  is  the  patch  testing.  Johnson 
and  Johnson,  for  example,  sends  out  some  surgical  gowns,  bandages, 
lotion  or  cream.  In  my  mind,  that  research  is  as  bothersome  and 
troublesome  as  the  significant  drug  research  or  the  malaria  testing. 

Would  we  allow  anyone  else  to  come  in  and  employ  these  prisoners? 
The  answer  is  no.  There  is  no  statutory  allowance  for  private  com- 
panies in  Pennsylvania  to  come  in  and  use  the  prisoners  for  whatever 
they  want. 

Under  the  banner  of  medical  science,  imder  which  many  significant 
achievements  have  been  forthcoming,  we  have  this  kind  of  meaning- 
less use  of  the  prisoner. 

Senator  Kennedy.  Would  your  point  be  as  viable  about  these  pris- 
oners bein^  available  to  private  industry  that  relates  to  commercial 
research  ?  What  about  science-based  research  ?  Do  you  draw  a  distinc- 
tion there? 


850 

Dr.  Capron.  Should  one  leave  it  up  to  the  individual  investigator  to 
distinguish  between  truly  significant  research  and  a  lot  of  rather  in- 
significant and  badly  controlled  research  ?  Even  in  the  true  interest  of 
science  I  am  not  sure  that  we  should  leave  it  up  to  the  individual 
scientist  to  evaluate  this.  It  presses  things  a  little  to  say  that  the 
scientists  has  a  commercial  interest  in  the  studies  involved,  but  the 
studies  that  have  been  done  indicate  that  scientists  do  have  a  very 
personal  interest.  Whether  you  quantitize  that  the  way  you  quantitize 
a  shareholder's  interest  in  a  company,  I  don't  knoAv.  I  leave  that  up  to 
you. 

Mr.  Hutt  testified  this  morning  that  the  FDA  requires  informed 
consent,  but  they  have  no  way  of  knowing  whether  informed  consent  is 
obtained.  I  would  also  like  to  correct  Miss  Adams.  This  morning,  she 
suggested  that  the  FDA  does  the  monitoring.  In  fact,  the  monitors  are 
employees  of  the  drug  companies. 

Senator  Kennedy.  What  would  it  take  to  involve  you  in  one  of  these 
drug  programs? 

Dr.  Capron.  Some  sort  of  convincing  evidence  that  the  drug  was 
something  that  was  needed  and  not  a  duplication,  which  is  what  most 
or  many  of  the  new  drugs  that  come  out  are. 

Senator  Kennedy.  You  would  be  willing  to  do  it? 

Dr.  Capron.  You  haven't  told  me  what  the  risk  involved  is  and  the 
like.  I  think  the  study  to  which  Miss  Mitford  referred  earlier  is  ac- 
curate. It  is  not  a  very  detailed  sociological  study ;  I  think  it  was  done 
by  physicians.^  It  showed,  however,  that  most  people  will  not  under- 
take malaria  testing,  whereas  there  is  a  greater  willingness  among 
prisoners  to  participate  in  malaria  research. 

In  looking  through  the  literature,  I  came  across  a  lot  of  malaria  re- 
search which  is  being  done,  including  the  giving  of  malaria  to  a 
syphilitic  patient.  That  is  another  constraint,  that  is,  your  Subcom- 
mittee should  look  at  the  person  in  the  hospital.  He  is  as  much  at  the 
physician's  beck  and  call  as  the  prisoner  is. 

Senator  Kennedy.  Do  you  think  we  ought  to  take  the  NIH  guide- 
lines and  enact  them  into  law  so  that  all  the  research  regardless  of  its 
funding  would  be  enforced  ? 

Dr.  Capron.  I  don't  think  the  DHEW  guidelines  will  provide  any- 
where near  enough  detail.  This  is  not  even  part  of  the  guidelines.  They 
say  only,  "Of  particular  concern  are  those  subjects  in  groups  with  lim- 
ited civil  freedom."  *  That  is  all  that  these  guidelines  contain  about 
prison  research,  although  I  think  prisons  are  an  extremely  different  en- 
vironment, which  require  special  standards  and  safeguards. 

In  a  hospital  where  you  have  first-class  physicians,  there  is  a  lot  of 
peer  discussion  of  what  research  is  going  on.  In  a  prison,  you  have  a 
locked  cellblock.  In  the  locked  cellblock  you  have  one  investigator  and 
his  assistants.  You  have  nobody  else  in  there  interacting  with  him, 
seeing  a  patient,  hearing  from  a  nurse  what  is  going  on.  We  learned 
from  our  experience  in  New  Haven  that  that  is  how  things  often  come 
to  light. 


3D.  C.  Martin.  J.  D.  Arnold.  T.  F.  Zimmerman.  &  R.  H.  Ricliart.  Human  Subjects  in 
CUnienl  Research,  279  new  eng.  j.  med.  1426  (196S)  (66%  of  prisoners  were  willinp  to 
volunteer  for  malaria  research,  but  only  7.5%  of  fire  and  policemen  and  none  of  the  profes- 
sionals interviewed  were  willine:  to  volunteer  ;  the  latter  groups  were  more  willing  to 
volunteer  for  research  on  drugs,  the  common  cold,  or  air  pollution.) 

*  U.S.  Department  of  Health.  Education,  and  Welfare.  "The  Institutional  Guide  to  DHEW 
Policy  on  Protection  of  Human  Subjects,"  2  (1971 ). 


851 

That  was  also  the  experience  that  was  reported  by  Dr.  Melmon  in  his 
article  in  the  New  England  Journal  about  the  review  committee  at  the 
University  of  California  Medical  School.^  Your  question  was  whether 
these  guidelines  are  adequate  for  prison  research  and  my  answer  is  no. 

Senator  Kennedy.  Dr.  Diamond,  let  me  ask  you — as  you  were  on  the 
peer  review  group  out  at  the  university — how  many  research  experi- 
ments did  you  turn  down  ? 

Dr.  Diamond.  In  some  six  years,  we  have  flatly  prohibited  only  one 
project.  That  was  for  improper  use  of  experimental  drugs  on  students. 
However,  we  require  modifications  of  the  research  design  or  some  of 
the  paperwork  such  as  consent  forms  or  who  they  get  consent  from,  I 
would  estimate,  in  approximately  one-third  of  all  the  projects  that  go 
through  the  university. 

Senator  Kennedy.  Thank  you  very  much,  gentlemen. 

[The  prepared  statement  of  Dr.  Capron  follows.] 


5  K.  L.  Melmon,  M.  Grossman,  and  R.  C.  Morris,  Jr.,  "Emerging  Assets  and  Liabilities  of 
a  Committee  on  Human  Welfare  and  Experimentation,"  282  New  Eng.  J.  Med.  427  (1970). 


852 

EXPERIMENTATION  WITH  PRISONERS 

Supplemental  Prepared  Statement 

Submitted  by 

Alexander  Morgan  Capron 

Assistant  Professor  of  Law 

University  of  Pennsylvania  Law  School 

Philadelphia,  Pennsylvania 

to  the 

HEALTH  SUBC(»fMITTEE 
Senate  Committee  on  Labor  and  Public  Welfare 
March  7,  1973 

Set  forth  below  under  ten  headings  is  a  survey  and  analysis  of 
what  seem  to  me  to  be  a  number  of  difficult  questions  raised  by  research 
on  captive  groups,  particularly  civilian  prisoners.  Two  bibliographies, 
one  giving  examples  of  research  studies  and  the  other  evaluative  and  critical 
%rritings,  are  also  included. 

1.  Nature  of  the  Subjects  Involved;  Much  experimentation  apparently 
takes  place  in  Jails  which  hold  pre-trial  inmates,  but  this  fact  is  generally 
not  discussed  in  the  medical  literature  nor  recognized  in  regulations.   In 
what  follows,  it  is  assumed  that  "prisoners"  are  limited  to  those  who  have 
been  convicted;  all  the  questions  raised  are  simply  underscored  and  made 
■ore  acute  when  detainees  awaiting  trial  are  involved. 

2.  Scientific  Aspects;  The  Justifications  usually  given  for  using 
prisoners  in  research  is  that  they  (1)  are  available,  (2)  have  an  obligation 

to  do  something  of  value  for  society,  and  (3)  are,  because  of  their  confinement, 
easily  controlled.  The  first  two  Justifications  are  problematic,  since 
"voluntarism"  is  still  a  generally  recognized  requirement;  although  all 
prisoners  have  a  "debt  to  society,"  not  all  are  "available" — -only  those: 
who  "choose"  to  participate. 

The  third  Justification  presents  a  more  complicated  picture.  There 
are  probably  many  experiments  in  which  it  is  necessary  (or  at  least  highly 
preferable)  to  be  able  to  confine  the  subjects  in  order  to  keep  careful 
control  of  their  activities,  diet,  etc.,  and  prisoners  are  obviously  easy 
to  control.  Yet  this  may  not  be  enough  reason  to  use  them  in  experiments. 
If  sufficient  scientific  or  monetary  reward  were  offered  by  a  project, 
"free  world"  persons  might  also  be  persuaded  to  volunteer,  despite  the 
inconvenience  of  confinement. 

There  are  also  dangers  that  the  use  of  prisoners  may  reduce  the  scientific 
accuracy  of  an  experiment.   First,  this  may  occur  if  prisoners  are 
disinclined  to  report  accurately  adverse  side-effects,  etc-.,  for  fear  of 
being  dropped  from  the  program  and  losing  benefits,  even  when  they  have  been 
assured  that  they  are  "free  to  withdraw"  and  still  get  paid.   Second,  the 
history  of  this  subject  indicates  that  less  care  is  taken  in  scientific 


853 


design  when  the  "experimental  material"  (I.e.  the  human  subject)  Is  relatively 
cheap,  as  prisoners  are.  This  danger  was  exhibited  most  tragically  by  the 
useless  results  of  much  of  the  Nazi  "experimentation"  revealed  at  Nuernberg, 
but  It  continues.   Recently,  Dr.  Lawrence  Kohn  pointed  out  that  typhoid 
experiments  carried  out  on  seventeen  healthy  Inmates  In  the  Maryland  House 
of  Corrections  "are  of  limited  value  since  the  food  Intake  of  the  subjects 
was  not  apparently  standardized."   278  N.E.J. Med.  739  (1968).  Yet  the 
reason  for  using  Inmates  was  that  their  conditions  were  supposedly 
readily  controlled  or  "standardized." 

3.  Status;  Why  be  concerned  that  the  subject  has  the  status  of  a 
prisoner?  What  relevance  does  this  have  for  medical  research?  The  primary 
concern  In  the  literature  Is  the  effect  of  the  prisoner's  status  on  his 
ability  to  give  valid  consent;  this  Is  discussed  below.   The  question 

of  status  may  also  be  relevant  to  a  consideration  of  the  scientific  merits 
of  research  as  was  suggested  In  the  foregoing  section. 

But  the  "status"  Issue  has  broader  significance that  is,  being  a 

prisoner  is  a  status  which  results  from  a  decision  by  the  state  which 
consequently  has  special  obligations  toward  prisoners.  At  the  very  least, 
it  is  not  possible  in  this  type  of  research  to  maintain  that  the  investigator 
can  proceed  entirely  "on  his  own,"  since  the  state  must,  at  the  very  least, 
give  him  permission  to  make  use  of  its  "captives."  The  conduct  of  experiments 
will  almost  certainly  Involve  some  direct  or  Indirect  expenses  for  the 
prison  system;  yet,  on  the  other  hand,  if  the  state  is  remunerated  for  the 
use  of  the  prisoners  there  is  a  danger  that  the  officials  will  be  less  than 
diligent  in  protecting  the  prisoners. 

Some  have  gone  so  far  as  to  argue  that  prisoners  should  never  be 
used  in  research.  Again,  the  abuses  of  the  Nazi  physicians  are  still  a 
vivid  memory.  The  World  Medical  Association's  Draft  Code  of  Ethics  on 
Human  Experimentation  (1961),  which  was  watered  down  before  it  was  adopted, 
provided : 

(c)  Prisoners  of  war,  military  or  civilian,  should  never  be 
used  as  subjects  of  experiment. 

(d)  Civilians  detained  in  any  place  as  a  result  of  military 
invasion  or  occupation,  or  for  administrative  or  political 
reasons,  should  never  be  used  for  human  experiment. 

These  provisions  would  find  general  assent  in  the  American  research 
community,  but  they  highlight  an  unresolved  issue:  what  are  the  obligations 
of  an  investigator  in  ascertaining  the  manner  in  which  a  person  was  imprisoned? 
Does  he  have  the  duty  to  reject  persons  whose  conviction  or  deten' ion  may 
be  improper  for  some  reason? 

4.  Consent:  The  "status"  issue  is  usually  raised  to  question  whether 
any  person  who  is  Imprisoned  can  validly  consent  to  an  experiment.   For 


93-999  O  -  73  -  pt.  3 


854 


example,  the  UMA's  Draft  Code  continues  as  follows: 

(e)  Persons  retained  In  prisons,  penitentiaries,  or  reformatories 

being  "captive  groups" should  not  be  used  as  subjects  of  experiment; 

nor  persons  Incapable  of  giving  consent  because  of  age,  mental 
Incapacity,  or  of  being  In  a  position  In  which  they  are  Incapable 
of  exercising  the  power  of  free  choice. 

The  Draft  Code  thus  argues  for  an  absolute  ban  on  prison  research,  which 
It  seems  to  base  In  prisoners'  being  "Incapable  of  exercising  free  choice." 

While  the  Ideal  of  free  and  fullylnformed  consent  Is  usually  given 
as  the  standard,  we  must  recognize  that  the  concept  Is  very  difficult  to 
apply  In  practice  and  many  people  make  choices  Irrationally  or  for  poor 
reasons.  Along  these  lines.  Prof.  Louis  Jaffe  has  objected  to  "excessive 
ethical  fastidiousness"  In  securing  prison  volunteers.   He  believes  that 
the  only  requirement  should  be  that  no  "undue  advantage"  be  taken  of  a 
prisoner  In  getting  his  consent;  he  argues  that  the  special  pressures 
of  being  in  prison  are  not  In  themselves  an  undue  advantage.  What  are 
those  pressures? 

(1)  Prisoners  may  fear  that  failure  to  join  an  experiment  will 
"get  them  in  trouble"  with  their  superiors. 

(2)  Participation  in  an  experiment  may  remove  the  prisoner 

from  his  ordinary  surroundings he  may  be  moved  to.  a  special 

ward  or  even  to  an  outside  hospital. 

(3)  Participation  may  permit  the  prisoner  to  overcome 
boredom  and  to  assert  slightly  greater  control  over  his  own 
life  and  activities. 

(4)  Particularly  where  the  experiment  takes  place  in  a  very 
poor  facility  (such  as  a  Jail  or  county  prison)  participation  may 
permit  the  prisoner  to  get  a  better  diet  and  more  comfortable 
accomodations  and  perhaps  to  escape  assault  by  his  fellow  Inmates. 

Many  of  these  pressures  which  constrain  the  prisoner's  "power  of  free  choice" 

nay  be  felt  by  others  who  are  subjects  of  research such  as  graduate  or 

medical  students  or  the  employees  of  pharmaceutical  companies,  all  of 
whom  would  be  especially  subject  to  the  first  pressure.  The  difference 
between  the  use  of  the  prisoner  and  these  other  groups  in  research  is  that 
in  the  case  of  the  prisoner  the  pressures  are  directly  generated  by  society 
and  they  are  subject  to  modification  or  elimination  by  state  officials  who 
have  custody  of  the  prisoners.   Therefore,  operating  an  experiment  in  a 
setting  in  which  these  pressures  act  on  the  prisoners  to  cause  them  to 
"volunteer"  may  not  be  a  neutral  matter. 


855 


5.  Rewards ;   In  addition  to  the  negative  factors  which  push  a 
prisoner  toward  participating  In  an  experiment,  one  must  also  be  concerned 
with  what  "rewards"  may  be  given.  There  are  two  major  types:  money  and 
reduction  in  sentence. 

Financial  rewards  pose  a  particularly  thorny  problem.  On  the  one 
hand,  complaint  is  often  made  that  prisoners  are  paid  for  too  little  for 
their  participation.  On  the  other  hand,  large  payments  would  seem  too  much 
like  taking  advantage  of  the  prisoner's  extreme  need,  both  for  himself  and 
perhaps  for  family  members. 

The  question  of  reducing  prison  sentences  first  arose  in  connection 
with  the  major  malaria  experiments  conducted  during  World  War  II  in 
the  Illinois  State  Penitentiary  at  Joliet.  After  the  War,  a  Committee  appointed 
by  the  Governor  recommended  that  reductions  in  sentences  be  permitted,  but 
that  prisoners  not  be  told  prior  to  an  experiment  the  extent  of  reduction  so 
as  to  avoid  influencing  him  directly.   Nevertheless,  prisoners  may  come  to 
expect  that  they  will  be  rewarded  with  early  parole  for  participating, 
especially  if  the  experiment  involves  danger. 

In  addition  to  its  consequences  for  the  prisoner,  rewarding  him  by 
granting  earlier  parole  also  has  an  obvious  effect  on  society.  The 
American  Medical  Association  took  up  on  one  recommendation  of  the  Governor's 
committee  and  resolved  in  1952  that  "persons  convicted  of  murder,  rape, 
arson,  kidnapping,  treason  or  other  heinous  crimes"  not  be  subjects  and  that 
"individuals  who  have  lost  their  citizenship  by  due  process  of  law  be 
considered  ineligible  for  meritorious  or  commendatory  citation." 

A  final,  less  tangible  reward  is  the  psychic  return  to  the  prisoner. 
He  may  feel  "altruistic"  or  "brave"  as  a  result  of  participating.   It  may 
also  elevate  his  status  among  his  fellow  inmates  and  his  family  and  friends 
outside  the  walls. 

6.  Limitations  on  Types  of  Research;  Although  "consent"  may  play  a 
major  role  in  the  experimentation  process,  it  is  clearly  not  enough.   The 
state  has  obvious  concern  with  limiting  the  types  of  research  which  nay  be 
conducted  on  persons  in  its  custody.  Although  never  well  articulated,  some 
degree  of  risk  may  simply  be  too  great  to  allow.  For  example,  should  a 
prisoner  be  permitted  to  give  a  kidney  in  a  research  program  on  transplantation? 
Such  a  program  was  operated  for  1  1/2  years  by  Dr.  Thomas  E.  Starzl  in 
Colorado  prisons  in  the  early  1960's,  but  he  stopped  the  program  because 

he  doubted  the  validity  of  the  consent  and  feared  that  it  "would  Inevitably 
lead  to  abuse  if  accepted  as  a  reasonable  precedent  and  applied  broadly." 

If  capital  punishment  1%  reintroduced  for  special  crimes  in  some 
states  (and  upheld  by  the  courts),  we  will  be  faced  again  with  the  special 
situation  in  which  it  is  argued  that  certain  research,  which  is  too  risky  to 


856 


perfona  on  any  other  normal  volunteers,  ought  to  be  offered  to  prisoners 
under  sentence  of  death.   Clearly,  it  would  not  be  permissible  to  offer 
the  prisoner  the  "reward"  of  not  dying  if  he  lived  through  the  experiment; 
that  would  be  wrong  to  society  and  and  undue  pressure  on  him  to  consent. 
Nor  does  the  sentence  of  death  justify  exposing  the  prisoner  to  a  painful 
or  nutilating  dying  process.  A  few  years  ago,  Jack  Kerokvian  proposed 
that  condemned  prisoners  should  "be  allowed  to  submit,  by  .  .  .  free  choice, 
to  medical  experimentation  under  complete  anesthesia  ...  as  a  form  of 
execution  in  lieu  of  conventional  methods."  He  argued  that  the  danger 
inherent  to  such  a  program  would  be  outweighed  by  the  benefits  to  science, 
society  and  to  the  prisoner  himself. 

7.  Peer  Review;  Under  both  HEW  and  FDA  guidelines  and  regulations, 
research  projects  must  receive  prior  approval  from  a  "peer  review" 
committee.  The  FDA  requires  that  "If  the  experimental  project  is  to  be 
coiulucted  on  institutionalized  subjects  .  .  .,  assurance  must  be  given  that 
an  Institutional  review  committee  is  responsible  for  initial  and  continuing 
review  and  approval  of  the  proposed  clinical  study.  The  membership  must 

be  comprised  of  sufficient  members  of  varying  background,  that  is,  lawyers, 
clergymen,  or  laymen  as  well  as  scientists,  to  assure  complete  and  adequate 
review  of  the  research  project."  21  C.F.R.  S130.3  (a) (12). 

Since  the  FDA  does  not  keep  a  central  registry  of  prison  experimentation, 
there  is  no  way  of  knowing  how  well  this  requirement  has  been  met  in 
prison  research.  Moreover,  the  paper  record  would  be  inadequate  to  reveal 
how  completely  the  conmittees  were  doing  their  job.  There  are  a  number 
of  weaknesses  with  the  entire  concept:  (1)  there  is  no  mechanism  for 
communication  among  the  institutional  review  committees,  a  problem  which 
goes  beyond  the  prison  setting;  (2)  it  is  difficult  to  see  how  a  small 
ad  hoc  group  appointed  by  the  prison  warden  is  well  situated  to  engage  in 
the  sophisticated  weighing  of  benefits  and  risks  which  would  be  required  for 
the  comoiittee  to  carry  out  the  function  which  seems  to  have  been  assigned  to 

It;  and  (3)  the  committee  does  not  have  the  backup  protection which  %iDuld 

exist  in  a  hospital  setting,  for  instance of  "policing"  by  the 

investigator's  true  peers,  his  fellow  scientists  and  psysicians. 

8.  Economics ;   It  is  usually  assumed  that  prison  research  has  a 

favorable  benefit/cost  ratio i.e.  that  vital  testing  (particularly  Phase  1 

drug  testing)  is  done  in  prisons  which  would  be  nearly  impossible  to  do 
otherwise.  Yet  the  very  weight  which  is  put  on  the  singularity  of  prison 
testing  suggests  that  the  "price"  we  pay  for  it  may  be  greater  than  we 
realize.  As  was  suggested  in  the  previous  section,  it  is  ridiculous  to 
expect  local  review  committees  to  be  able  to  evaluate  the  overall  benefits 
to  science  and  society  of  particular  tests  or  of  testing  in  general.  This  is 
very  plainly  a  "political"  judgment,  and  as  such  is  appropriate  for  careful 
legislative  consideration  and  resolution. 

9.  Exploitation;  One  "price"  that  may  be  paid  through  permitting 
prison  research  is  that  prisoners  are  exploited,  which  they  may  resent  and 


857 


which  may  thus  Interfere  with  their  rehabilitation.   It  is  often  said  that 
prisoners  appreciate  the  opportunity  to  earn  money  (for  use  in  the  prison 
canteen)  and  to  gain  other  benefits,  already  discussed.  On  the  other  hand, 
most  prisoners  are  only  paid  50  cents  a  day  for  participating.  Some  states 
have  laws  forbidding  the  contracting  out  of  prisoners'  services  to  private 
concerns.   Even  were  such  a  practice  permitted,  a  compensation  of 
$.50/day  would  usually  be  viewed  as  exploitative. 

Much  of  the  research  which  is  carried  out  in  prisons  involves  little 
risk,  of  course.   (For  example,  the  testing  of  dyes  for  skin  reactions,  etc.) 
Yet  the  routine  nature  of  the  testing  only  serves  to  make  more  apparent  that 
the  prisoners  are  being  used  in  the  same  way  a  corporation  uses  its  other 
employees  or  equipment.  Not  all  routine  activities  are  free  of  risk, 
however.  Dr.  Austin  R.  Stough's  plasmapheresis  program  in  the  Alabama  prison 
system  from  1962-64,  for  example,  amounted  to  the  use  of  the  inmates  as 

regular  blood  "producers"  not  as  subjects  for  innovative  medicine and 

yet  374  prisoners  came  down  with  hepatitis  and  three  died. 

10.  Enforcement;  A  final  issue  which  deserves  serious  attention 
concerns  the  need  for  better  enforcement  mechanisms.  At  present,  only 
the  civil  law  of  damages  provides  any  means  of  control  (through  tort 
cases),  and  the  effectiveness  of  that  means  is  compromised  because  researchers 
routinely  get  "waivers"  from  all  prisoner-subjects  stating  that  they  will 
not  sue  the  investigator  or  the  prison  system  for  any  Injuries  suffered. 
Consequently,  inmates  participating  in  experiments  may  not  pursue  their 
remedies.  Moreover,  given  the  limited  field  staff  assigned  to  this  area, 
it  would  only  be  chance  if  a  federal  review  officer  were  to  uncover  situations 
in  which  the  proper  steps  had  not  been  taken  to  obtain  institutional  committee 
approval  or  to  Inform  inmate-subjects  of  risks,  etc.   Before  he  "resigned" 
Dr.  Robert  Marston,  former  NIH  director,  announcedlast  November  10^^  that 
NIH  was  convening  a  group  to  suggest  new  regulation  for  research  on 
prisoners  and  other  institutionalized  or  Incompetent  subjects;  the  committee 
had  had  one  preliminary  meeting  as  of  February  10,  1973. 


858 


-7- 
BIBLIOGRAPHIES 


Studies 

Beye,  H, ,  K,  Getz,  G.  Coatney,  H,  Elder  and  D,  ilyle^. 

Simian  Malaria  In  Man,  10  _nmerican  Journal  of  Tropical 
Medicine  and  Hygiene  311  (T961 ). 

Slumber;;,  o.,  S,  Kuvin,  J.  Ronj  nson,  J.  Teitelbaum,   nd 

P.  Gontacos,  Alterations  in  H.-ir>to/-10i.)in  i^cvels.  1  81l  J,/i.K..i 
10,i1  (1963).  

Branson,  S,,  and  Z,    Bent,  Immunolot^ic  i'Jxperience  c.t   Men's 
Correctional  Center,  60  Journal  of  the  haine  l-iedjcal 
Asaociation  213  (1969).  ■~~"  ~~ 

Dobbs,  D,,  and  L,  Speck,  Visual  invoked  Resoonse  and  Frequency 
Density  3,->ectra  of  Prisoner  Patients,  9  Comprehensive 
Psychiatry  62  (1963). 

Peigin,  H.,  A.  Klainer,  W,  Beisel,  and  R,   Hornick,  '.Vhole-Blood 
Amino  Acids  in  Experimentally  Induced  Typhoid  Fever  in 
Man,  278  New  England  Journal  of  Medicine'  293  (1968). 

Guerrero,  M,,  Mental  Disorders  in  Prison  Inmates,  29  Ji seas as 
of  tne  Nervous  System  320  (1968). 

Heller,  C,,  and  Y,  Clermont,  Kinetics  of  the  Germnal  Epi- 
thelium in  Man,  G.  Pincus,  ed,:   20  Hecent  Proa;rQ33  in 
Hormone  Research,  (^"©w  York:   Academic  Press  5q-5f  .1 96I4.) , 

Hodges,  H,,  J.  Hood,  J.  Canham,  H,  Sauberlich,  and  K,    Baker, 
Clinical  Manifestations  of  Ascorbic  Acid  Deficiency  in 
Man,  2l\.   ■\meri»an  Journal  of  Clinical  Nutrition  i|.32  (1971  )• 

Hedges,  R,,  E,  Baker,  J,  Hood,  H.  Sauberlich  -^nd   S,  March, 

^x^-^rimental  Scurvy  in  Man,  22  American  Journal  of  Clinical 
Nutrition  535  (1969).         

Hodges,  H.,  "That's  New  About  Scurvy?.  2ii  .merjc  an  Journal  of 
Clinical  Nutrition  383  (1971). 

Kuvin,  3.,  H.  Beve,  F.  Stohlman,  P.  Gontacos,  and  G,  Coatney, 
Malaria  in  Man,  1 8I4.  J. A.M. A.  101 8  (1963). 

Mattocks,  A.,  and  C.  Jew,  Assessment  of  an  .iversive  'Contract" 
Program  with  Extreme  Acting-Cut  Criminal  Offenders, 
Unpublished  lianuscriot  (1971 )»  printed  in  J.  Katz  with 
A.M.  Capron  &  E.S.  Glass,  Experimentation  with  Human  Beings 
1016  (New  York  I  Russell  Sage  Foundation,  1972). 


859 


-8- 


Resnick   0,,  The  Psychoactive  Properties  of  Di  )henylhydantoin: 
Experiences  with  Prisoners  and  Juvenile  Delinquents,  3 
Supp .  2  International  Journal  of  Neuropsychiatry  ( 1 9o7 ) . 

Stoffer,  ^■>,,    J.  Sanir.'s  ^nd  3.  Meketon,  Behavior  in  i'ix-Addict 
Fomale  Prisoners  Participating  in  a  Rosc-.irch  otudy,  10 
Comprehensive  Psychiatry  Z''-k   (196l|). 


Evaluations 

Arnold,  J,,  D,  Martin,  S,  Boyer,  a  Study  of  One  Prison  Population 
and  Its  :-iesoonse  to  i-edical  itesoai'ch,  1  o9  .ainals  of  the 
New  York  Academy  of  ociences  i|.63  (1970), 

Kyd,  P.,  Drug  Studies  in  Prison  Volunteers,  65  qcu thorn  i:edical 
Journal  Ijij.O  (1972). 

Ayd,  F,,  I'iotivations  and  Rewards  for  /oluntcerinr'  to  be  an 

Experimental  Subject,  13  Clinical  Phnrmnooln  ;/  nnd  'Php.r»pfti]ti  ns 
771  (1972). 

Ayd,  F.,  B,  31ackv:ell,  Study  Group  (yd  hoc):   r-sycaotrooic 

Drug  ^valuation  in  Prison  Volunteers,  7-^  Psychophsj'macology 
Quiletin  35  (1971-1972). 

Blackvrell,  3,,  For  the  First  Time  in  Mrm,  13  Clinical  Pharma- 
cology  and  Therapeutics  d12  (1972). 

Gudr;'.n,  J,,  Intcllif^ence  of  Volunteers  as  H'^scarcli  Subjects, 
33  Journal  of  Consulting  and  Cl'nical  Psycho lo.oiy  501  (1969). 

■Jstelle,  ^'!,,    The  Changing  Prof :' le  and  Conditions  Surroxinding 
Clinical  Research  in  •'riaons,  13  Clinical  Pharriiucc  logy 
and  Therapeutics  O3I  (  1972). 

Peigin  Pi.,  a, .Klairaer,  W,  Beisel,  d,   liornick.  Prisoners  as 
Experimental  Subjects,  278  New  I^gland  Journal  of  Medicine 
1128  (1968). 

Hodges,  R,,  and  W,  Bean,  The  Use  of  Prisoners  for  Medical 
Research,  202  J. A.M. A.  513  (1967). 

Joneja,  M.,  A.  Travill,  and  G,  Scott,  Chromosomal  Studies 

of  Prison  Inmates  with  Relationship  to  Offence  Characteristics, 
17  Canadian  Psychiatric  Association  Journal  1i4.7  (1972). 

Kliraan,  A.,  Australia  Antigen  in  Volunteer  and  Paid  Blood 
Donors,  28U  New  iCngland  Journal  of  Medicine  109  (1971). 


860 


-9- 


Lasagna,    L,,    Drug  Evaluation   Probloms   in   Academic    and  other 

Contexts,    169   /uinals   of  the   N.Y.    ;.cariemy  of  Science  503    (1970), 

Marstcn,    R.,    Research  on  Minors,    Prisoners    £uid  tho  I.entally 
111,    21-SQ   Nevj   '^.^(-.l-md   Journal   of  liodlc:'ne    15^    (1V73). 

FcDonald,    J.,    Why   Prisoners    Volunteer   to   be    •:x-:)erin;ntal    .Subjects, 

202   J.:..Ii.A.  ^11  (V:67). 

McMahon,  F,,  The  "llormal" Prisoner  in  Kedical  research, 13 
Journal  of  Clinical  Phariimtp6a.Qgy71  (197^). 

Morris,  R,,  Guidelines  for  .vcceoting  Volunteers:   Consent, 
Ethical  Implications,  and  the  Function  of  £•.  Peer  .{eviow,' 
13  Clinical  PharmacolOfsy  and  Therapeutics  7^'--  (  1973. 

Huniz,  F.,  H,  Malyska,  W,  Levin,  ^m  ;\ntigen  in  Blood  from 

Prisonoers,  23U,   Nov;  i^nglrmd  Journal  of  iie'iicine  501  (1971). 

Zeisel,  H,,  Reducing  the  Hazards  of  Human  Experiments  Throu  ;h 
liodifi  c.tions  in  Research  Design,  169  Annals  of  the  New 
York  .icademy  of  3cineces  J|75  (1970), 

See  also  Katz,  J,  with  A.M.  Capron  &  E.S.  Glass,  Experi- 
mentatilon  %Ah  Human  Beings  (New  Yorki  Russell  Sage  Foundation, 
1972)  for  additional  evaluative  articles,  esp,  pp.  1013-52, 
dealing  with  "captive"  subjects. 


861 


March  12*  1979 


\fr 


Hon.  Edvard  K«im«d7 
8alt«  431 

8«n«t«  Of flea  ftuildlnt 
Uaitsd  StatM  SaaaC* 

Waahlngcoo,  D.  C. 


Daar  Sanator  Kannadji 

It  was  a  pleaaura  to  partidpata  in  your  haaringa  on  htaaan  axparlmantatlon 
thia  paat  Wadnaaday.  Tba  work  your  aubcoiil  ttaa  la  doing  ia  vitally  iaportaat, 
not  only  in  praparing  inforaation  for  tha  lagialatioa  you  aay  decida  to 
draft  but  alao  in  alarting  tha  public  to  tha  aarioua  iaauaa  raiaad  by  husan 
caaaarch  and  in  proapting  action  on  tha  part  of  tha  varioua  fadaral  aganciaa 
Imrolvad.  Ona  raault  of  yOur  hearinga  vill  ba,  I  am  aura,  that  tha  Food 
and  Drug  Adainiatration  will  taka  anothar  look  at  the  laval  of  covplianea 
with  ita  Inatitutional  Raviev  Conmittae  raquireaant  and,  I  hopa»  will  aaand 
tha  regulationa  ao  aa  to  require  (aa  KIEW  doea)  docuaantation  that  proper 
comlttee  review  and  approval  has  taken  place.  Indeed,  both  the  PDA  and 
DUKW  ahould  aove  beyond  praaent  regulationa  to  infom  thenaalvaa  about  the 
content  of  "Inforotad  Conaaat"  foraa  and  the  proeaduraa  through  which  they 
are  actually  adainiatared. 

I  thought  your  probing  of  Mr.  Stetler  of  the  RfA  waa  particularly 
enlightening.  Uia  reaponaea  tended  to  obacure  a  nuaber  of  pointa,  however, 
Pirot,  when  the  queation  of  added  coota  of  noa->panal  aubjaota  for  drug 
tea  ting  ia  raiaad,  it  ia  wall  to  kaap  in  aiad  that  thia  ia  a  $8  billi<m/year 
induatry,  which  ia  eatiaatad  to  riaa  to  $11.4  billion/year  by  1980.  It 
ia  not  aa  though  one  were  talking  about  iapoaing  a  heavy  burden  on  a  poor 
atruggling  acientiat. 

Second,  aany  phyaidana  and  pharaacologiata  do  not  ahare  Mr.  Statlar'a 
view  about  the  need  to  conduct  Phaae  I  atudiaa  on  "noraala.**  While  vaccina 
triala  auat,  obvloualy,  be  done  on  people  who  have  not  previoualy  baan 
naturally  axpoaed  to  tha  d;(aaaaa  in  quaation,  thia  aay  not  be  true  far  other 
d^ruga.  Tou  Bight  conaider  taking  taatiaony  in  tha  future  on  thia  aubject 
froB  people  who  repraaant  tha  '*acience'*  aa  wall  aa  tha  "buaiaaaa**  aide  of 
Che  drug  induatry.  Of  oourae,  the  uaa  of  aick  people  aa  teat  a«^jacCa 
ralaaa  ethical  problaaa  of  ita  own. 


862 


2  March  U,  1973 


Third,  4tm  •hotttd  b«  c— ticww  4homt  accflptivg  Mr.  Sc«tX«r*s  mvkt 
dMt  pri»«mmrm  mxm  i4*«t  •ahj«ct«  b«c«we  th«ir  teawtrovmrnnt  1«  so  clM«ly  ' 
•OBtroUW.  It  IM   Hiic—itfj  t»  t«lM  lato  accovat  th«  tmonut  of  drug  «b««« 
•hlch  o«cu^  t»:»ri— »  («sp«eiallj  in  pr«trl«l  d«t«ttti<m  facilities »  whar* 
a  t*M>d  daal  tff  taatiag  appaara  to  ha  condoctad) ,  tha  fact  that  aany  prlao«ara 
mx*  aoc  In  tha  haat  phyalcal  condition  vbaa  thaj  aatar  tha  laatltution, 
tha  fact  that  aany  prlaaaara  do  not  T«Mtin  on  a  strict  prison  dlat  bat 
smypliMsnt  thalr  aaala  vith  food  pvrdiasad  at  tha  cniaitssary  (paid  for  vith 
funds  aaraad  m»   raaaarch  snbJactaT),  ate.  Noo'-druf  raaaarch  m»f  alao  ba 
sohjaat  to  siallar  ptoblasw,  mm   la  Indicatad  by  tha  coiaants  of  Dr.  La»r4 
Kahai,  concamiag  tha  Maryland  tyi^id  a^parlBants*  ^tsotad  on  paga  evo  of 
Wj  aapplimtal  atatsnwBt  anbaittad  at  tha  haarli«. 


Mr.  Statlar  aaggaacnd  that  "salf-rafnlatlon'*  by  drag  cowpaniaa  vaa 
sfproprlata  and  ada^aata  for  tha  problaa.  I  wondar  vfaathar  paat  actions 
by  tha  drag  cwyauisa  aupporta  thia  TlairT  As  Mr.  Lavson  tastifiad. 
Dr.  Albart  Fllyian  (ahoaa  Ivy  Kaaesrdi  L^s  conducts  axpariaaata  in  tha 
ftailadalphia  county  priaons)  was  sospaadad  by  tha  FD4  la  1966.  At  that 
tlaa,  tha  drug  coapaniaa  aspraaaad  auprlaa  and  coneam  ovar  tha  auapaoaion 
(uhiah  vaa  liftad  aftar  ona  nontft).  Dr.  Francaa  Kalaay  of  tha  FDA  talla  mm 
that  alBca  1967  ai^K  invaatlgatora  hava  bean  auspandad.  Did  tha  drag  esf  ani< 
aatialpata  attf  of  thaaa  aight  sospanaions  and  act  to  rsaova  tha  iarvaatigatora 
prior  to  tha  n)A*a  soMuacaMantT  Bava  thay  evar  takan  ao^  action  on  thalr 
own? 

It  la  uBlikaly  ti»at  a  drug  coapasy  would  act  againat  an  lavas tigator»  ' 
far  a  nabar  of  raaaona.   (1)  Tha  coupaay  nay  ba  unaware  of  tha  haavy 
wolws  of  raaaardb  diat  tiM  ianraatigator  la  carrying  on— 'wfalch  la  ona  of  tha 
waya  which  tha  FDA  is  alartad  to  poaaibla  problaaa  aincf  it  la  awara  of 
tha  raporta  ttf  isrvaatigatar  la  taming  in  to  all  hia  rwpawlaa.  (2)  Soo- 
BoaAcally,  thara  la  littla  incantiwa  for  a  drug  coapai^  to  diacontlana  an 
loNraatigator  wboaa  a^ica  or  nathoda  ara  quaatlonabla,  ainca  it  la  llkaly 
that  auch  imraatlgatora  can  provida  thalr  aarvica  aora  chaaply  than  thalr 
■ora  acrupuloua  and  caraful  collaaguaa. 

Ona  final  co^Mat  for  tha  raoord*  if  I  a^y.  In  ny  taatlaooy  I 
attsaptad  to  "corract**  a  atataaant  aada  by  Miaa  Allaan  Adaas  concaming 
tha  FDA*s  "aonitoriiv'*  of  drag  taata.  Both  Mlas  Adsas  and  I  had  tha  aaaa 
Intantlon,  I  baliava:  to  point  out  that  at  praaant  tha  FDA* a  ataff  la 
unabla  to  do  an  adaquata  Job  of  actually  aaklng  sura  thst  drug  trlala  ara 
proparly  condoctad.  I  wlahad  only  to  daar  up  tha  lapraasion  which  sha 
mtj   have  created  that  tha  f^A  preaently  haa  the  priaary  obligation  to 
"aoaitor**  tha  ceaduet  of  taata.  Aa  I  underataad  it,  the  tern  *'aonitor" 
daacribaa  aa  aiployse  af  the  drug  coapany  (either  ln-4M>uaa  or  apedally 
retained  for  the  purpoae)  who  la  auppoaed  to  be  the  liaiaon  between  the 
canpany  end  tha  iavaatigatar*  to  eocplalB  tha  w^  la  which  the  teat  will 
ba  run,  to  aaka  aora  that  tha  facilitlaa  ara  adaquata,  to  acquaint  tha 


863 


Itorch  12,  1973 


1^  lorMtisator  vich  hi*  l«ial  dblltatioiM  to  the  rabjcets,  etc.  (8m 

foT  «uapl»»  21  CR  1130.3  («)(S),  which  •!:«£••  am  m  condition  of  rocoiTlflg 

on  invootigational  aov  drag  asMqitiOB  that  "Tho  opoooor  Bonitoro.cho  progroas  «^  ^ 

otc. ,  «ad  ID  Fom  1571  vhidh  roqairoo  tho  oponoor  Ci^o.  tho  drug  coapaiqf)       I 

to  Mhait  •  staMMHit  of  tlM  qoalif  icotiono  of  ito  ■onitero.) 


Iho  riM^  4o«o  try  to  ''■oaifeoi:  tho  aoaiton**  through  its  inopoctoro, 
'  iiio  will  oloo  occooionftllj  ^ock  vp  on  «n  invootigator  directly.  This 
l—o icoriag  has  ia  l^ia  paat  occur ed,  hovovor,  only  "for  caaao**  (i.a.  trtiaa    .^'^  % 
mm  aboao  or  diahooaaty  ia  Vrought  to  the  FM'a  attaatioa)  or  vhan  tho  lacf^ 
aaoant  of  raaoarcb  balog  reportad  by  a  aia^o  invoatigator  laada  tho  FDiA 
to  quoation  vhothav  ho  oaai  hO  parfomiag  valid  atndioa.  Thoro  ar«  only  a       ^ 
fov  pMplo  aaalgned  to  thia  vork,  aa  I  aadaratand.  For  actual  iiivoatigatioaj|«,  ^  ' 
tho  TDk  off ieiala  ia  charga  (Dr.  Kalaay  and  Dr.  Liaook)  nuat  call  oh  the 
400  or  so  fiald  inapectora,  lAo  aro  alao  roaponaibla  for  iaapocting  factorioa, 
chocking  tba  quality  of  food  found  in  aopormarkota,  auperviaing  tho  oparation 
mi  nathadon  naintonaaca  progr«ui,  ate.  The  inapoctora  (who  h«ve  a  200-C     .  *  .  ^^ 
orodaatial  rating)  ara  being  givan  a  apecial  mix-Mmtk  **craah  conrao**  to    ;  ''%C  % 
propare  th«i  to  inapaec  tba  vork  of  clinical  iavaatigatara.  Tiaar  canaittaa  *  V  -  >^^ 
:  ,hlght  want  to  give  fnrthar  canaidaration  to  tho  qnaatioa  whather  tha  FBiA'a 
>;;'i««pbna^llitiaa  for  actnally  ■onitorlng  all  reaearcfa  (or  raadoa  caaaa,  mm 
1  ilM  FDA  mtif  now  bo  prapavlag  to  do  itaalf)  would  inprove  tha  quality  of  Cha 
roaoarch  aad  tha  care  with  whi^  it  ia  undartaiMn  or  would  aarely  add  further    ^ 
and  unnaceaaary  buraaucracy.  ^. 

laeidaitally,  you  mmf  be  intereatad  to  know  tkmt   tho  Vednoaday  hoariags    y 
gat  a  good  deal  of  covaraga  here  in  Philadelphia.  I  an  endoaing  a  copy 
of  aa  articla  fron  tha  PailT  Pennaylvanian  that  I  thought  you  would  like  tm-mtimiji- 
Ihara  ia  ■ach  concern  about  priaon  reae«rch  in  thia  atate,  and  the  office 
of  the  Attorney  Conaral  haa  ezpreaaed  intoreat  in  the  '*aoratoriua**  concept 
which  I  auggeatod  to  your  caauitteo.  Deciaiona  on  a  atate-by^atate  baaia        '^ 
ivottld  only  aarra  to  enphaaiaa  tha  need  for  a  unif om  Federal  q»proach,  I  baliaNrla*^ ' 

'.;   mth  boat  wiahaa  to  you  on  thia  ia^ortant  taak,  I  an. 

Cordially  youra. 


Alaxaader  M.  Capron 
Aaaiatant  Prof eaaor  of  Law 


AMCsocy 


864 

Senator  Kennedy.  Our  next  witness  will  be  Mr.  C.  Joseph  Stetler, 
President  of  the  Pharmaceutical  Manufacturers  Association.  He 
joined  the  staff  of  the  Pharmaceutical  Manufacturers  Association  in 
1963.  He  was  Executive  Vice  President  and  General  Counsel  and 
then  became  President. 

We  welcome  you  to  the  committee. 

STATEMENT  OF  C.  JOSEPH  STETLER,  PRESIDENT,  PHARMACEUTI- 
CAL MANUFACTURERS  ASSOCIATION,  WASHINGTON,  D.C.,  AC- 
COMPANIED BY  JOHN  G.  ADAMS,  PH.  D.,  PMA  VICE  PRESIDENT 
FOR  SCIENTIFIC  AND  PROFESSIONAL  RELATIONS,  AND  BRUCE  J. 
BRENNAN,  PMA  VICE  PRESIDENT  AND  GENERAL  COUNSEL 

Mr.  Stetler.  Thank  you,  Mr.  Chairman.  I  am  C.  Joseph  Stetler, 
President  of  the  Parmaceutical  Manufacturers  Association.  With  me 
today  are  Dr.  John  G.  Adams,  Ph.  D.,  PMA  Vice  President  for  Scien- 
tific and  Professional  Relations;  and  Bruce  J.  Brennan,  PMA  Vice 
President  and  General  Counsel. 

We  would  like  to  insert  our  long  statement  in  the  record  and  I  will 
proceed  with  my  testimony. 

Senator  Kennedy.  It  will  be  so  admitted  in  the  record  at  the  end  of 
testimony. 

[The  material  referred  to  w^as  not  available  for  the  record  at  the 
time  of  printing.] 

Mr.  Stetler.  It  is  our  understanding  that  the  committee  is  interested 
today  primarily  in  the  use  of  volunteere  in  drug  testing,  and  particu- 
larly in  such  testing  among  prisoners  recruited  for  that  purpose.  As 
requested,  my  oral  statement  will  be  very  brief. 

In  drug  research,  the  need  to  test  candidate  compounds  in  human 
beings  prior  to  broad-scale  marketing  is  obvious.  Even  the  most  ex- 
tensive animal  trials  cannot  be  relied  upon  to  predict  the  safety,  mode 
of  action,  or  the  therapeutic  effectiveness  of  any  drug  m  man.  Useful  as 
animal  data  is,  it  provides  only  approximate  indices  of  the  safety  of  a 
new  drug  in  man  and  affords  only  a  general  understanding  of  how 
the  compound  may  be  absorbed,  metabolized,  excreted,  and  of  its 
pharmacologic  effects. 

When  animal  data  is  encouraging,  we  still  arrive  at  an  unavoidable 
j)oint  of  fact:  The  proper  vehicle  for  testing  a  drug's  potential  for 
man  is  man. 

It  is  important  to  understand  that  in  these  early  studies  of  a  candi- 
date drug  safety,  rather  than  efficacy,  is  being  investigated.  These  first 
tests  in  man,  referred  to  as  Phase  I  Trials,  are  restricted  to  very  small 
numbers  of  human  subjects.  They  may  include  single  or  multiple  dose 
regimens  over  relatively  short  periods  of  time  in  order  to  obtain  data 
on  the  overall  pharmacological  and  biochemical  characteristics  of  the 
compound.  The  experiments  provide  useful  parameters  on  appropriate 
dosage  levels  and  indications  as  to  the  levels  at  which  side  effects  might 
be  expected  to  appear  in  patients. 

For  a  number  of  reasons  outlined  in  my  longer  statement,  these  first 
trials  are  conducted  primarily  in  healthy,  normal  persons. 

To  do  this  kind  of  Phase  I  research  properly,  a  number  of  conditions 
are  desirable : 

I  have  listed  a  couple  in  the  longer  statement. 


865  . 

One  would  be  that  relatively  homogenous  subjects  should  be  studied 
in  order  to  facilitate  the  design  of  studies  from  which  relatively  pre- 
cise conclusions  could  be  reached  in  relatively  little  time. 

Second,  the  study  group  should  be  healthy.  This  allows  the  re- 
search team  to  study  the  effects  of  a  carefully  controlled  escalation  of 
dosage  under  close  supervision,  with  maximum  safety. 

Third,  for  the  conclusion  to  be  valid,  only  one  variable — the  drug — 
should  be  present.  The  study  group,  and  the  test  environment — time, 
place,  diet,  exercise,  et  cetera — should  be  held  constant,  insofar  as  that 
is  possible. 

Fourth,  attention  to  detail  must  be  explicit.  Phase  I  studies  in  par- 
ticular require  many  tedious  and  repetitive  procedures,  such  as  fre- 
quent blood,  urine,  blood  pressure,  pulse  and  respiration  tests. 

Given  the  widespread  use  of  pirsoners  in  this  testing  at  the  present 
time  we  recognize  that  consideration  must  still  be  given  to  the  moti- 
vations behind  the  prisoners'  willingness  to  participate  in  these 
studies,  to  the  manner  in  which  they  are  conducted,  to  the  protections 
afforded  and  to  actions  which  should  be  considered  for  further  im- 
proving the  practice. 

While  it  is  unquestionably  essential  to  provide  prisoners  who  join  in 
drug  studies  with  the  same  information  and  levels  of  protection  that 
all  other  enjoy,  we  should  also  recognize  that  there  are  unique  benefits 
which  prisoners  gain  from  taking  part  in  these  programs. 

There  seems  to  be  general  agreement  that  either  the  most,  or  one  of 
the  most,  important  factors  behind  prisoner  participation  in  test  proj- 
ects is  financial  reward. 

Senator  Kennedy.  Couldn't  the  community  as  a  whole  have  similar 
motivation  ?  Wouldn't  other  people  go  for  this  other  than  prisoners  ? 

Mr.  Stetler.  I  don't  doubt  that,  but  the  financial  reward  might  be 
so  high  that  it  would  make  these  tests  prohibitive.  You  might  have  a 
larger  number  of  people  anxious  and  willing  to  participate. 

Senator  Kennedy.  How  many  people  do  you  need  ? 

Mr.  Stetler.  For  Phase  I  testing,  we  are  talking  about  10  or  12 
people. 

Senator  Kennedy.  How  much  are  vou  talking  about  ?  What  do  you 
offer  them  in  the  prison,  $25  to  $50  ? 

Mr.  Stetler.  There  are  two  factors  to  be  considered.  One  is  the 
incentive  for  people  to  volunteer  and  the  other  is  that  to  do  the  phase 
I  studies,  you  have  to  do  them  under  carefully  controlled  circum- 
stances. Are  you  going  to  get  12  normal,  healthy  people  to  go  into  a 
hospital  routine  for  2  weeks  ? 

Senator  Kennedy.  What  percentage  of  the  phase  I  studies  have  to 
be  under  that  kind  of  supervision,  in  a  hospital  ? 

Mr.  Stetler.  Most  of  the  testing  has  to  be  in  a  controlled  environ- 
ment. For  the  people  who  are  eligible  to  participate  in  the  phase  I 
trials,  I  think  this  would  be  a  substantial  deterrent. 

Senator  Kennedy.  What  percentage  is  necessary?  What  are  the 
types  of  things  that  you  are  talking  about?  You  don't  think  that  you 
could  for  a  couple  of  hundred  dollars  get  people  to  come  down  to  a 
clinic  ? 

Mr.  Stetler.  As  I  mentioned,  some  of  the  other  thingfs  involved  are 
diet,  exercise,  sleep.  In  other  words,  you  just  wouldn't  control  them 


866 

properly  by  checking  them  in  and  out  of  a  clinic.  You  would  have  to 
have  24-hour  control  over  these  people. 

Senator  Kennedy.  What  percentage  of  the  needed  24  hours  is 
controlled  ? 

Mr.  Stetler.  Much  of  it.  Not  that  the  testing  is  going  on  all  that 
time,  but  the  subjects  are  subject  to  24-hour  surveillance. 

Senator  Kennedy.  Most  of  the  prisoners  are  moved  out  of  their 
cells? 

Mr.  Stetler.  Yes ;  many  of  them. 

Senator  Kennedy.  What  percentage  are  ? 

Mr.  Stetler.  Many  of  them  are  taken  into  the  hospital  facilities. 
They  are  certainly  removed  from  their  everyday  prison  routine. 

Senator  Kennedy.  They  stay  in  the  infirmary  or  what? 

Mr.  Stetler.  Many  of  them  do. 

Senator  Kennedy.  What  percentage  of  them  ? 

Mr.  Stetler.  I  can't  tell  you  exactly,  but  it  is  a  high  percentage. 

Senator  Kennedy.  Your  position  is  you  couldn't  get  other  citizens  in 
the  community,  even  given  the  financial  remuneration,  to  undertake 
this  type  discipline  ? 

Mr.  Stetler.  I  can't  say  "couldn't"  because  it  has  not  been  tried. 

Senator  Kennedy.  It  has  or  has  not  been  tried  ? 

Mr.  Stetler.  It  has  not  been  tried. 

Senator  Kennedy.  Why  has  it  not  been  tried  ? 

Mr.  Stetler.  I  suppose  because  it  is  too  difficult. 

Senator  Kennedy.  You  haven't  tried  yet.  How  do  you  know  it  is 
difficult? 

Mr.  Stetler.  You  get  back  to  the  other  points  I  mentioned  earlier. 
When  you  have  others  available,  you  use  them. 

Senator  Kennedy.  Is  that  because  it  is  cheaper  ? 

Mr.  Stetler.  It  is  cheaper. 

Senator  Kennedy.  It  is  your  testimony  that  the  other  would  be  too 
expensive  ? 

Mr.  Stetler.  No.  My  statement  was  not  that.  Also  on  the  fees,  the 
fees  are  acknowledgeably  low.  However,  the  fees  are  set  by  the  prison 
officials  in  the  vast  majority  of  cases  and  they  are  set  at  that  rate  be- 
cause all  labor  that  is  paid  for  in  prisons  is  extremely  low. 

As  the  men  previous  to  me  have  testified,  they  worked  in  prisons  for 
50  cents  and  $1  a  day.  The  officials  keep  these  fees  low  for  medical 
experiments  on  purpose  so  that  they  don't  have  a  distorted  picture. 

I  think  the  exploitation  exists  when  prisoners  are  used  at  those  low 
rates  to  do  the  other  things  that  they  do  in  prisons.  The  exploitation  is 
probably  in  that  to  a  larger  degree. 

Senator  Kennedy.  Do  the  drug  companies  pay  any  prison  officials 
at  all  ? 

Mr.  Stetler.  We  pay  directly 

Senator  Kennedy.  Why  don't  you  continue  ? 

Mr.  Stetler.  As  I  mentioned,  the  most  important  factor  behind 
prisoner  participation  in  test  projects  is  financial  reward.  In  general, 
however,  the  fees  are  structured  so  as  to  avoid  any  financial  coercion 
that  might  occur  if  drug  testing  were  unusually  rewarding  relative  to 
pay  rates  for  other  prison  work.  Except  in  rare  instances,  the  amount 
the  prisoner  receives  is  decided  by  prison  officials  and  not  by  the  spon- 
sors of  the  research. 


867 

Significant  as  the  financial  incentive  is,  it  would  be  a  mistake  to  con- 
clude that  it  is  the  only  motivation.  Studies  have  shown  that  prisoners 
have  additional  reasons  for  participating.  Many  hope  to  escape  the 
tediousness  of  prison  life ;  to  be  part  of  a  commendable  effort ;  to  show 
themselves  and  others  that  they  can  do  good  and  worthwhile  things ; 
to  gain  acknowledgement  as  individuals  deserving  respect;  to  show 
authorities  that  they  are  reforming.  Many  are  merely  seeking  a  pur- 
pose or  involvement  to  escape  boredom. 

Records  show^  that  prisoners  rarely  break  rules  or  have  disciplinary 
problems  while  in  the  testing  programs.  Volunteers  are  plentiful  and 
while  they  are  always  free  to  leave  the  project,  they  rarely  do  so,  appar- 
ently feeling  that  their  role  is  useful  which,  of  course,  it  is. 

Our  feeling  is  that  these  experiences  are  of  significant  value  to  the 
prisoners  and  that  we  should  not  deny  willing  prisoners  the  opportuni- 
ties, so  long  as  their  health  and  their  civil  liberties  are  protected. 

Senator  Kennedy.  ^Vliat  has  been  your  reaction  to  the  kinds  of 
statements  that  ha\^  been  made  here  this  morning  about  the  kind  of 
life  within  those  prisons  being  sufficiently  desperate  that  these  people 
will  grab  at  any  straw  ? 

Mr.  Stetler.  Unfortunately,  in  many  prisons  we  have  a  dismal 
situation. 

Senator  Kennedy.  You  still  have  experimentation  going  on  in  those 
areas  ? 

Mr.  Stetler.  We  have  in  some,  but  you  also  find  in  some  of  these 
facilities  that  they  are  absolutely  properly  conducted.  Take  the  facili- 
ties run  by  several  of  our  companies  in  the  Mid  West.  We  actually  have 
some  responsibility  for  part  of  the  prison  operation.  We  sometimes 
take  the  prisoners  into  a  hospital  wing  of  a  separate  hospital.  Under 
those  conditions  where  we  do  control  it,  we  are  convinced  that  it  is 
handled  properly  and  that  they  have  the  proper  medical  examinations 
in  advance  and  they  are  well-informed  and  that  their  consent  in  the 
matter  is  informed. 

In  some  of  those  situations,  and  maybe  improperly,  these  projects  are 
given  to  independent  investigators  who  have  access  to  prisons  and 
prison  populations  and  they  have  assumed  the  responsibility  for  insur- 
ing proper  consent. 

Senator  Kennedy.  What  happens  after  they  go  into  that  nice  clinic  ? 
Then  what  do  they  do,  go  back  to  the  prison  cell  ? 

Mr.  Stetler.  Yes,  they  go  back  to  the  prison  cell.  However,  in  one  of 
our  companies,  they  w  ill  only  use  people  who  are  within  six  months  of 
completing  their  prison  terms. 

In  other  w^ords,  to  the  extent  it  is  possible  to  impro\ne  the  status  of 
the  people  that  are  involved,  some  good  efforts  have  been  made. 

Senator  Kennedy.  Do  you  see  any  responsibility  for  the  pharma- 
ceutical industry  in  looking  out  after  the  general  medical  condition  of 
prisoners  if  they  use  a  particular  group  of  prisoners  for  research  ? 

Mr.  Stetler.  Yes,  I  w  ould  and  I  do. 

Senator  Kennedy.  What  are  they  doing  about  it,  if  anything? 

Mr.  Stetler.  It  is  spotty.  I  think  it  runs  from  very  good  to  inade- 
quate. Certainly,  they  have  to  have  appropriate  assurances.  It  is  not 
only  required  by  regulations,  but  it  is  required  by  a  good,  moral 
approach  to  the  problem,  that  the  people  are  healthy,  that  they  have 
good  continual  medical  surveillance  while  they  are  under  the  program. 


868 

As  to  whether  they  have  any  follow-up  responsibility,  I  am  sure  that 
would  be  debatable. 

Certainly,  in  my  opinion,  if  there  are  any  after  effects  from  their 
participation  in  the  program,  the  responsibility  exists.  This  business  of 
waivers — there  is  no  place  for  that.  Although  it  does  exist  it  is  not  as 
extensive  as  has  been  indicated  this  morning.  To  the  extent  that  it  does 
exist,  it  should  not.  It  is  legally  unenforceable.  The  only  thing  it  does 
is  to  mix  a  prisoner  up. 

Senator  Kennedy.  If  the  fact  that  you  are  going  to  pay  a  prisoner 
disrupts  the  life  of  a  prison  community,  why  don't  you  establish  a 
trust  fund  to  pay  the  prisoner  when  he  gets  out  ? 

Mr.  Stetler.  I  am  not  sure  about  that.  If  he  has  been  involved  in  a 
minimal  experiment  where  his  blood  pressure  has  been  taken  three 
times  a  day  for  ten  days,  I  don't  think  we  have  that  responsibility. 

Senator  Kennedy.  Why  couldn't  you  do  that  outside  ? 

Mr.  Stetler.  Because  blood  pressure  is  a  very  difficult  think  to  meas- 
ure. You  must  measure  it  under  particular  conditions.  You  are  not 
going  to  get  a  necessary  uniform  result  when  blood  pressure  is  taken 
on  the  outside.  You  have  to  have  the  subject  in  a  controlled  situation. 

Senator  Kennedy.  Do  you  mean  staying  in  their  cells  or  doing  work 
in  the  prison  ? 

Mr.  Stetler.  They  are  in  hospitals. 

Senator  Kennedy.  Why  wouldn't  it  be  possible  to  make  some  kind 
of  arrangement  with  the  prison  so  that  when  they  are  released  so  that 
besides  the  $25,  they  get  other  compensation  ? 

Mr.  Stetler.  Along  that  line,  many  of  our  companies  do  make  con- 
tributions to  the  funds  that  are  used  for  the  general  use  of  the  prison 
populations. 

Senator  Kennedy.  How  much  have  they  done,  say  last  year? 

Mr.  Stetler.  I  can't  tell  you,  but  I  can  tell  you  that  it  is  not  an 
exceptional  situation.  I  might  be  able  to  find  out. 

Senator  Kennedy.  You  don't  know  how  many  are  doing  it  ? 

Mr.  Stetler.  I  know  that  some  are. 

Senator  Kennedy.  Do  you  know  the  amounts '? 

Mr.  Stetler.  I  do  not. 

Senator  Kennedy.  Have  you  explored  that  possibility  of  setting  up 
some  kind  of  a  trust  so  that  the  people,  after  they  would  get  out,  would 
be  able  to  be  additionally  compensated  ? 

Mr.  Steti.er.  No,  I  have  not. 

I  would  like  to  describe  some  of  the  procedures  followed  in  prison 
tests  sponsored  by  pharmaceutical  houses.  I  should  point  out  that  of 
necessity  my  description  will  be  general,  reflecting  what  we  under- 
stand to  be  the  typical  practice.  As  you  know,  situations  vary  widely ; 
some  firms  operate  and  staff  their  own  facilities  within  the  prison; 
some  maintain  prison  wards  in  general  hospitals;  others  sponsor  re- 
search conducted  by  individual  investigators ;  and  still  others  employ 
institutional  contractors. 

Test  projects  in  prisons,  like  all  clinical  trials,  must  be  the  subject 
of  investigational  new  drug  exemptions  (INDs)  filed  with  the  FDA. 
The  IND  gives  complete  details  on  the  purpose  and  methodology  to  be 
employed,  describes  the  number  and  characteristics  of  the  subjects, 
and  the  qualifications  of  the  investigator. 


869 

Additionally,  when  institutionalized  patients  are  involved,  a  local 
review  committee  must  be  empaneled,  and  its  membei'ship  must  be  of 
varied  background,  including  clergymen  or  other  laymen,  as  well  as 
scientists.  The  investigator  must  assure  the  sponsoring  company  and 
the  FDA  that  the  research  program  will  not  be  started  without  the 
review  committee's  approval. 

The  basis  for  the  clinical  study  is  the  protocol,  which  is  a  matter  of 
extensive  discussion  and  consideration  before  the  study  is  initiated. 
The  sponsoring  firm  should  determine  that  the  institution  where  the 
research  is  to  be  conducted  has  adequate  facilities,  personnel  and  labo- 
ratories. Before  final  agreement,  the  investigator  must  accept  the  pro- 
tocol and  the  conditions  of  the  investigation.  He  is  made  aware  of  the 
pertinent  regulations  governing  investigations,  including  consent  pro- 
cedures, adverse  reaction  reporting  rules,  and  other  requirements. 

The  researcher  is  given  toxicologic  and  pharmacologic  data  on  the 
drug  he  will  be  studying,  as  well  as  other  meaningful  facts.  Through- 
out the  course  of  the  study,  communication  with  the  investigator  is 
maintained  at  appropriate  intervals,  by  mail,  telephone  or  on-site 
visits. 

No  prisoner  is  to  be  started  on  the  project  until  he  has  had  a  physical 
examination  and  is  advised  as  to  the  nature  of  the  study  and  the  risks 
that  are  involved.  The  information  is  recorded  on  the  consent  form 
which  is  read  to  him,  about  which  he  certainly  may  ask  questions,  be- 
fore signing.  He  is  told  that  he  may  withdraw  from  the  study  at  any 
time,  and  that  fact  is  stipulated  on  the  consent  form. 

The  pharmaceutical  industry,  through  drug  testing  programs,  is 
definitely  involved  in  prisoners'  lives,  and  that  involvement,  we  be- 
lieve, has  to  be  productive  for  prisoners  and  for  society  in  general. 
We  acknowledge  an  obligation  to  do  what  we  can  to  improve  still 
further  the  manner  in  which  testing  is  performed  in  correctional  insti- 
tutions. Errors  and  injuries  have  doubtless  occurred,  but  they  are  rare 
by  comparison  to  the  number  of  prisoners  who  have  successfully  taken 
part  in  the  studies. 

In  recent  days,  we  have  contacted  the  leadership  of  the  National 
Council  on  Crime  and  Delinquency  in  order  to  gain  that  organization's 
advice  and  assistance  in  formulating  possible  improvements.  We  have 
discussed  the  convening  of  a  broad  cross-section  of  experts  in  medicine, 
industry,  penology,  and  public  policy  to  discuss  the  subject  in  detail. 
One  outcome  of  such  a  meeting  might  be  a  special  set  of  guidelines 
for  the  protection  of  prisoners'  rights  in  medical  research.  I  have  every 
confidence  that  we  can,  as  an  industry,  work  constructively  with  such  a  . 
body,  to  better  serve  the  interests  of  prisoners  who  help  to  make  ad- 
vances in  drug  therapy  available  for  us  all. 

At  the  moment,  we  believe  that  legislative  action  in  this  area  is  not 
indicated.  We  have,  however,  noted  with  interest  the  introduction  of 
bills  S.  878  and  S.  974,  93d  Congress.  We  believe  that  such  approaches 
merit  broad  support  and  approval. 

I  hope  that  our  comments  have  been  responsive  to  the  committee's 

area  of  interest.  We  will  be  happy  to  attempt  to  answer  your  questions. 

Senator  Kennedy.  Thank  you  very  much,  Mr.  Stetler. 

We  welcome  Senator  Javits  and  Senator  Pell.  We  heard  testimony 

that  the  Food  and  Drug  Administration  is  not  aware  of  the  serious 


93-999  O  -  73  -  pt.  3  --  6 


870 

research  programs  that  are  taking  place  in  these  various  prisons.  They 
are  unable  to  furnish  any  list  of  these  programs. 

Can  you  tell  us  what  percent  of  phase  I  drug  experimentation  is 
taking  place  on  prisoners  today  ? 

Mr.  Stetler.  The  Food  and  Drug  Administration  is  apprised  by  us 
of  all  of  the  phase  I  studies  that  are  conducted  in  prisons.  They  don't 
know  about  medical  experimentation  in  general,  Ibut  with  respect  to 
the  drugs,  they  know. 

I  think  the  misunderstanding  was  that  they  do  not  have  in  a  corre- 
lated way  an  ability  to  supply  this  information,  but  they  have  it  on 
individual  IND's. 

The  percentage  of  phase  I  studies  done  with  prisoners  is  very  high. 
I  would  say  maybe  70  percent. 

Senator  Kennedy.  What  is  the  other  30  percent  ? 

Mr.  Stetler.  Some  of  the  anticancer  drugs  covered,  which  are  re- 
ferred to  in  the  longer  statement,  would  be  too  dangerous  to  use  in 
healthy  persons  and  they  are  used  in  phase  I  in  the  people  with  the 
diseases  which  we  are  trying  to  correct  or  treat. 

Senator  Kennedy.  With  the  exception  of  the  drugs  that  are  con- 
sidered to  be  dangerous  drugs,  pretty  much  all  of  them  are  being  used 
in  prisons ;  is  that  right  ? 

Mr.  Stetler.  There  would  be  possibly  another  10  percent  that  would 
be  used  initially  in  medical  students  or  sometimes  the  people  engaged 
in  the  research  subject  themselves  to  the  testing. 

Senator  Kennedy.  Medical  students  are  subject  to  an  open 
environment  ? 

Mr.  Stetler.  That  is  why  they  are  poor  subjects  and  they  are  a 
lower  percentage  of  the  total  used. 

Senator  Kennedy.  But  you  can  use  10  percent  of  them? 

Mr.  Stetler.  Only  with  respect  to  use  testing  certain  drugs. 

Senator  Kennedy.  But  you  don't  use  any  other  civilians,  in  effect? 

!Mr.  Stetler.  There  might  be  sometimes  when  patients  in  hospitals 
could  be  used. 

Senator  Kennedy.  Individual  cases? 

Mr.  Stetler.  In  selection  where  you  had  relatively  well  people  in 
hospitals,  they  might  be  used.  But  it  is  relatively  a  small  percentage. 

Senator  Kennedy.  Do  you  have  a  list  of  all  the  testing  that  is  taking 
place  now  ?  Do  you  have  that  information  ? 

Mr.  Stetler.  No.  I  don't  think  it  is  accumulated  in  one  place.  The 
only  repository  for  it  are  the  individual  IND's  filed  with  FDA  and 
they  remain  an  individual  list. 

Senator  Kennedy.  Could  you  prepare  such  a  composite? 

Mr.  Stetler.  Theoretically,  I  could,  if  the  information  were  avail- 
able to  me.  It  is  not  available  to  us. 

Mr.  Brennan.  Much  of  this  information  could  not  lawfully  be 
made  available  to  us  because  it  is  a  trade  secret  on  developing  research. 
The  FDA  requires  of  us  the  exact  places  where  our  studies  are  taking 
place.  They  have  that  information. 

Senator  Kennedy.  We  listened  this  morning  to  the  testimony  of 
Jessica  Mitford,  who  indicated  that  there  is  no  such  experimentation 
taking  place  in  England  with  prisoners.  How  do  they  do  it? 

Mr.  Stetler.  It  is  generally  accepted  that  they  don't  do  testing  on 
prisoners. 


871 

Senator  Kennedy.  How  do  they  do  it  ? 

Mr.  Stetler.  You  have  a  different  set  of  regulatory  requirements  in 
Europe  and  the  United  States.  In  the  United  States,  we  have  a  virtual 
requirement  from  Food  and  Drug  that  Phase  I  be  conducted  in  nor- 
mal, healthy  individuals.  That  is  not  a  requirement  in  Europe. 

If  you  have  those  requirements,  you  have  to  follow  them.  In  other 
words  in  Europe  they  began  their  Phase  I  testing  with  people  with  the 
diseases,  the  conditions  which  the  drugs  are  intended  to  treat.  We  get  to 
that  with  Phase  II  and  III  in  this  country. 

You  have  a  different  approach  to  clinical  testing  in  Europe  and  the 
United  States.  I  don't  want  to  imply  that  it  is  only  an  FDA  require- 
ment that  suggests  that  normal,  healthy  individuals  be  used.  There  is 
also  a  scientific  consensus  that  you  are  better  off  if  you  do  your  im- 
partial testing  in  normal,  healthy  individuals.  The  feeling  is  the  sys- 
tem is  better  to  do  it  this  way. 

Senator  Kennedy.  The  American  pharmaceutical  companies  t^t 
abroad,  don't  they  ? 

Mr.  Stetler.  Yes. 

Senator  Kennedy.  What  do  they  do  over  there  ? 

Mr.  StetLcER.  When  you  test  abroad,  you  have  to  comply  with  the 
regulations  in  the  country  where  you  are  doing  the  research. 

Senator  Kennedy.  What  percentage  do  you  test  over  there? 

Mr.  Stetler.  I  have  to  conjecture  on  that.  I  would  say  maybe  20 
percent  of  your  testing  is  done  abroad. 

Senator  Kennedy.  You  have  to  comply  with  their  standards  ? 

Mr.  Stetler.  Yes. 

Senator  Kennedy.  Is  it  your  testimony  that  as  a  result  of  those 
tests  or  research  they  are  not  as  valid  or  accurate? 

Mr.  Stetler.  I  can't  say  that,  although  I  can  state  that  it  is  the  con- 
sensus of  the  scientists  in  this  country  that  it  is  a  better  scientific  pro- 
cedure to  begin  with  healthy  human  beings.  I  guess  you  could  say  from 
that  that  we  have  a  better  procedure  in  the  United  States. 

Senator  Kennedy.  They  don't  experiment  on  healthy  students? 

Mr.  Stetler.  They  can. 

Senator  Kennedy.  How  do  they  get  the  ones  they  need  ? 

Mr.  Stetler.  I  don't  know. 

Senator  Kennedy.  We  talked  earlier  about  the  fact  that  some  of  the 
drug  companies  have  prison  officials  on  their  payrolls  or  some  prison 
officials  receive  pay  from  pharmaceutical  companies. 

Mr.  Stetler.  I  don't  know  if  it  exists.  We  do  have  arrangements 
with  independent  investigators  where  we  will  give  them  a  certain 
amount  to  do  a  set  study  and  they  will  do  the  study  in  the  prison,  but 
they  are  not  prison  officials. 

Senator  Kennedy.  What  are  these  supposed  to  be  designed  for? 

Mr.  Stetler.  The  protocols  indicate  what  we  want  to  find  out  in 
Phase  I. 

Senator  Kennedy.  They  are  receiving  some  compensation  ? 

Mr.  Stetler.  Yes,  they  are. 

Senator  Kennedy.  Do  they  or  do  they  not  make  recommendations 
as  to  whether  drugs  are  safe  or  not  safe  for  use  ? 

Mr.  Stetler.  They  report  to  us  what  they  find  out.  They  would  give 
us  their  opinion,  too. 


872 

Senator  Kennedy.  Are  you  familiar  with  that  case  down  in  Talla- 
hassee, Florida  where  the  drug  firms  reportedly  paid  $7,000  during  a 
two-year  period  to  a  hospital  supervisor  while  he  was  passing  judg- 
ment on  the  safety  of  their  tests,  the  State  Corrections  Divisions  rec- 
ords show  this.  Are  you  familiar  with  that  ?  Do  you  know  about  that 
Florida  story  ? 

Mr.  Stetler.  Is  it  a  recent  case  ? 

Senator  Kennedy.  December  24,  1972,  is  the  date  on  this.  We  will 
include  it  in  the  record. 

[The  information  referred  to  follows :] 

[From  the  Tallahassee  Democrat,  Dec.  24,  1972] 

Prison  Drug  Tests  Benefit  Supervisors 

(By  Tom  Raum) 

Tallahassee  (AP) — Pharmaceutical  firms  experimenting  with  Florida  prison 
inmates  pay  thousands  of  dollars  each  year  to  prison  doctors  and  hospital 
supervisors  who  help  with  the  tests  and  sometimes  judge  their  effectiveness. 

Drug  firms  reported  paying  one  hospital  supervisor  more  than  $7,000  during 
a  two-year  period  while  he  was  passing  judgment  on  the  safety  of  their  tests, 
State  Corrections  Division  records  show. 

The  supervisor,  Dr.  Carlos  Hernandez,  is  in  charge  of  the  hospital  at  Union 
Correctional  Institution  near  Raiford  and  also  serves  as  medical  director  for  the 
entire  state  prison  system. 

The  payments  are  made  despite  a  state  policy  prohibiting  prison  system 
employes  from  accepting  outside  employment  if  it  involves  state  space,  state 
equipment,  regular  working  hours  or  a  potential  conflict  of  interest. 

A  study  by  the  Associated  Press  of  drug  experiments  in  Florida  institutions 
also  revealed  that  prison  hospital  supervisors  have  received  as  much  as  $2,225 
from  drug  firms  for  participating  in  a  single  experiment.  The  fees  seldom  run 
less  than  $400. 

(The  St.  Petersburg  Times  reported  Dec.  20  that  Florida  prisoners  were  par- 
ticipating in  drug  tests  and  that  the  state's  screening  of  tests  had  been  toughened 
to  prevent  any  that  might  be  hazardous  to  participants. ) 

Inmates  who  volunteer  for  drug  experiments  are  paid  varying  amounts,  gener- 
ally between  $15  and  $30. 

Nationwide  attention  has  been  focused  on  human  experimentation  since  the 
recent  disclosure  of  a  40-year  federal  study  in  which  treatment  was  withheld 
from  black  Alabama  syphilis  victims  so  the  the  disease  could  be  studied.  At 
least  28  men  died  as  a  direct  result  of  not  receiving  treatment. 

During  the  past  two  years,  60  experiments  were  conducted  in  Florida  prisons 
involving  4,122  inmates.  Products  tested  ranged  from  new  vaccines  for  influenza 
and  rabies  to  hair  shampoo. 

Last  summer,  Emmett  Roberts,  State  Health  and  Rehabilitative  Services 
secretary,  clamped  a  moratorium  on  all  drug  tests  in  Florida  until  better  pro- 
cedures could  be  established. 

The  moratorium  was  lifted  last  month  as  new  procedures  went  into  effect 
requiring  drug  firms  to  accept  full  liability  if  anything  goes  wrong  and  pro- 
hibiting tests  involving  juveniles  and  mentally  retarded  patients. 

But  the  new  procedures  did  nothing  to  change  the  long  standing  tradition 
permitting  drug  companies  to  pay  prison  doctors  and  other  prison  employes  fees 
for  services  rendered — supposedly  in  off  hours. 

In  records  filed  with  the  state  by  drug  companies,  Hernandez  is  listed  as 
receiving  $7,502  in  17  drug  projects  during  the  past  two  years. 

Hernandez  said  in  an  interview  he  did  not  keep  all  of  the  money  but  spread 
some  of  it — along  with  the  assignments — among  other  staff  doctors. 

But  other  staff  doctors  at  the  Union  hospital  were  also  listed  on  a  number  of 
reports  as  being  paid  separately. 

Duties  assigned  to  Hernandez  and  other  staff  doctors  in  exchange  for  the  fees 
from  the  drug  firms  generally  only  involved  "being  available"  in  case  of  emer- 
gency, Hernandez  said. 

A  memo  to  Hernandez  dated  June  7,  1971,  from  a  representative  of  Parke 
Davis  Co.  asked  him  to  provide  "medical  coverage"  on  a  proposed  experiment 
expected  to  last  18  months. 


873 

"This  coverage  should  require  very  little  time  or  effort  for  the  physician 
participating,"  the  memo  said.  "The  project  budget  includes  a  retainer  fee  in  the 
amount  of  $1,000  for  this  service." 

On  June  24,  Hernandez  sent  a  memo  to  prison  Supt.  L.  E.  Dugger  concerning 
the  same  experiment. 

"The  study  can  be  conducted  with  little  hazard  to  the  inmate  volunteer," 
it  said. 

Files  on  drug  tests  at  the  Union  institution — formerly  part  of  Raiford  State 
Prison — show  many  other  examples  of  memos  from  Hernandez  to  Dugger  ap- 
proving a  test  and  payment  schedules  showing  Hernandez  later  receiving  a  fee 
from  the  drug  firm. 

Although  principle  jurisdiction  over  evaluating  drug  experiment  proposals 
rests  with  the  Protocol  Review  Committee — composed  of  four  medical  professors 
from  the  University  of  Florida  Medical  School  and  one  non-medical  professor — 
Hernandez  had  life  or  death  powers  over  any  proposed  test  at  Union. 

He  denied  receiving  money  from  drug  firms  conflicted  in  any  way  with 
his  duties  as  hospital  supervisor  or  with  his  responsibilities  of  determining  the 
safety  of  the  tests. 

"The  pharmaceutical  companies  know  I'm  working  for  the  Division  of  Cor- 
rections and  not  for  them,"  Hernandez  said.  "If  I  see  something  I  don't  like  in 
an  experiment,  I  stop  it  right  away." 
Hernandez  said  the  work  he  did  for  drug  companies  was  on  off  hours. 
Hernandez  said  he  and  others  on  his  staff  keep  track  of  their  hours  on  a  time 
sheet  to  make  sure  they  don't  work  for  the  drug  companies  on  state  time. 

A  spokesman  for  Parke  Davis — which  contributed  a  substantial  portion  of  the 
$7,502  payments  to  Hernandez — said  prison  doctors  are  retained  for  backup 
medical  coverage  "because  they're  available." 

Parke  Davis  leases  a  wing  of  the  Union  prison  hospital  from  the  state  solely 
for  drug  experiments. 

Hernandez  was  not  the  only  hospital  supervisor  or  doctor  to  accept  payments 
from  drug  companies. 

William  E.  Phillips,  hospital  supervisor  at  Glades  Correctional  Institution, 
received  payments  of  $300  and  $2,225  during  the  past  two  years  for  helping  out 
in  a  test  by  Sandoz  Pharmaceuticals  on  a  new  antihistamine  for  hay  fever  and 
in  a  test  by  Warner  Lambert  Pharmaceuticals  on  a  tranquilizer  drug. 

The  $2,225  fee  for  the  six-month  long  Warner  Lambert  project  was  paid  despite 
the  fact  that  the  file  on  the  experiment  contains  a  memo  to  Corrections  Director 
Louis  Wainwright  from  a  prison  oflScial  at  Glades  complaining  that  the  length 
of  the  experiment  could  "result  in  a  disciplne  problem." 

The  tranquilizer  test  also  brought  Glades  laboratory  technician  William  Tim- 
mis  $1,025. 

Drug  companies  routinely  paid  lesser  amounts  to  other  prison  employes^ — in- 
cluding those  who  performed  custodial  services. 

Health  and  Rehabilitative  Services  Secretary  Roberts  said  the  payments  to 
state  employes  by  drug  firms  could  be  a  violation  of  his  department's  moonlight- 
ing rules. 

He  said  that  if  work  done  for  the  drug  companies  interefered  in  any  way  with 
the  employe's  job,  required  the  use  of  state  space  or  state  equipment  or  involved 
a  conflict  of  interest,  then  it  was  in  violation  of  the  policy. 

"I  plan  to  look  at  this  very  closely,"  he  said.  "Extra  care  will  have  to  be  taken 
in  the  future." 

Roberts  said  he  has  named  a  drug  utilization  committee  to  look  over  all  facets 
of  the  use  of  drugs — including  experimentation — at  state  institutons. 

"We're  going  to  get  a  detailed  study  done,"  said  Roberts.  "If  it  turns  out  that 
having  these  experiments  is  too  much  trouble,  then  I  wouldn't  mind  if  the  whole 
thing  went  out — if  we  just  said,  'no  more.'  " 


[From  the  Tallahassee  Democrat,  Dec.  28,  1972] 
Probe  Is  Ordered  of  Private  Payment  in  Prison  Drug  Tests 

(ByTomRaum) 

TALLAHASSEE     (AP)— Florida    Health    Secretary    Emmet    Roberts    said 
Wednesday  that  he  has  ordered  an  investigation  into  disclosures  that  drug  com- 


874 

panies  are  paying  prison  hospital  officials  to  help  them  conduct  experiments  on 
inmates. 

Roberts  said  a  departmental  committee  will  try  to  determine  if  the  practice 
violates  state  conflict-of-interest  rules  against  dual  employment. 

"The  questions  raised  are  a  deep  concern  to  me,  and  I  want  a  thorough  look 
into  all  the  ramifications,"  said  Roberts,  head  of  the  Department  of  Health  and 
Rehabilitative  Services. 

Records  filed  with  the  Department  of  Corrections  show  that  pharmaceutical 
firms  experimenting  with  Florida  prison  inmates  i)ay  thousands  of  dollars  each 
year  to  prison  doctors  and  hospital  supervisors  who  assist  with  the  tests  and 
sometimes  pass  judgment  on  their  safety. 

Dr.  Carlo  Hernandez,  medical  director  at  Union  Correctional  Institution  near 
Raiford,  was  listed  as  receiving  payments  totaling  more  than  $7,000  from  drug 
firms  over  a  two-year  period. 

Hernandez  has  denied  that  his  work  for  the  drug  companies,  which  mainly 
consisted  of  being  on  hand  in  case  anything  went  wrong,  i^  a  conflict  of  interest 
with  his  state  position — one  that  often  requires  him  to  rule  on  the  safety  of 
the  tests  before  they  are  conducted. 

Prison-system  employes  are  prohibited  from  accepting  outside  employment  if 
it  involves  state  space,  state  equipment,  regular  working  hours  or  a  potential 
conflict  of  interest.  Roberts  said  that  on  the  surface  the  payment  of  prison 
doctors  by  drug  firms  appears  to  be  in  direct  violation  of  this  policy. 

Roberts  said  he  has  asked  the  Drug  Utilization  Committee,  formed  earlier  this 
year,  to  "look  at  the  problem  and  see  what  is  the  best  course  for  the  inmates 
as  well  as  the  state." 

He  said  he  hopes  to  have  the  committee's  report  by  mid-January  and  will  post- 
pone taking  any  action  until  then. 

"I  am  disturbed  about  this,  and  I  intend  to  follow  through,  but  not  until  I've 
gotten  the  facts  from  all  sides,"  he  said. 

Roberts  said  the  committee  also  will  investigate  disclosures  that  members  of 
the  Protocol  Review  Committee — a  committee  of  four  University  of  Florida  Med- 
ical School  professors  and  one  layman  created  to  review  all  proposed  drug  ex- 
periments— often  conduct  such  tests  themselves  and  sometimes  even  enter  into 
research  contracts  with  drug  companies. 

He  said  the  Drug  Utilization  Committee  was  first  named  to  do  a  complete 
review  of  inmate  protection  in  drug  experiments  and  other  related  matters  in- 
volving the  use  of  drugs  in  state  institutions. 

"Now  I  intend  to  have  it  delve  into  all  these  other  angles  as  well,"  Roberts 
said. 

Gov.  Reubin  Askew,  to  whom  Roberts  reports,  is  waiting  to  see  what  action 
Roberts  will  take  regarding  possible  conflicts  of  interest  from  dual  employment 
before  looking  into  the  problem  on  his  own,  said  Askew's  press  secretary,  Don 
Pride. 


[From  the  Tallahassee  Democrat,  Dec.  2i5,  1972] 

Florida  Prisoners  Assist  in  Testing  of  New  Drugs 

(By  Tom  Raum) 

Raiford — Some  prisoners  may  participate  in  drug  experiments  to  make  a  con- 
tribution to  society  while  others  do  it  for  the  free  physical  examination.  But  most 
volunteer  solely  for  money,  says  a  state  corrections  official. 

"What  money  an  inmate  gets  out  of  this  program  is  about  all  he  get»,"  said 
L.  E.  Dugger,  superintendent  of  the  Union  Correctional  Institution  at  Raiford. 
"He  really  has  no  other  source  of  income." 

Dugger  said  inmates  use-  the  money  to  make  purchases  in  the  canteen  and  to 
send  home  to  their  families.  He  said  strict  procedures  at  the  prison  and  the  state 
level  governing  drug  tests  protect  inmates  from  risking  their  health  solely  for 
monetary  reasons.  "      * 

"We  think  we  have  adequate  safeguards,"  said  Dagger. 

Of  the  60  drug  te^ts  conducted  in  Florida  prisons  in  the  past  two  years,  38 
were  performed  at  Union,  Florida's  largest  state  prison. 

One  of  the  nation's  major  pharmaceutical  firms,  Parke  Davis  Co.  has  a  perma-' 
nent  experimentation  center  in  a  wing  of  the  prison  hospital,  space  it  leases  from 
the  state. 


876 

Dr.  Meigs  Haggerty,  the  Parke  Davis  representative  here,  agrees  that  few  in- 
mates would  show  up  if  they  weren't  paid. 

Pay  to  inmates  can  vary  widely  depending  upon  the  experiment,  ranging  from 
as  low  as  a  few  dollars  up  to  $200.  Haggerty  said  the  pay  scale  is  based  "mainly 
on  what  we  do  to  each  one." 

"For  instance,  it's  so  much  every  time  they  swallow  a  pill,  and  so  on.  It's  a 
dollar  everytime  a  needle  goes  in,  25  cents  every  time  we  take  a  urine  sample," 
he  said. 

Parke  Davis  and  other  drug  firms  also  pay  prison  hospital  doctors  and  tech- 
nicians— in  some  cases  thousands  of  dollars — for  helping  with  tests  despite  a 
state  ban  on  payments  to  state  employes  that  could  involve  a  conflict  of  interest. 

Only  one  drug  test  is  under  way  in  the  Parke  Davis  compound  now,  involving 
a  new  oral  vaccine  thought  to  be  effective  in  combatting  the  so-called  London  flu. 
Six  hundred  prisoners  are  participating. 

If  it  proves  successful,  said  Haggerty,  "the  vaccine  will  be  on  the  market  next 
year." 

During  the  past  two  years,  inmates  have  tested  cough  syrups,  a  new  rabies 
vaccine,  fly  vaccines,  medicine  for  arthritis,  epilepsy  and  tuberculosis,  a  host  of 
antibiotics  and  pain  killers,  cold  compounds  and  transquilizers. 

They  subjected  themselves  to  dizziness,  nausea,  vomiting,  intentional  exposure 
to  the  Hong  Kong  flu,  temporary  hearing  losses,  hives  and  considerable  soreness. 

A  moratorium  was  imposed  on  all  drug  tests  last  summer  by  Health  and  Re- 
habilitative Services  Secretary  Emmett  Roberts.  The  moratorium  has  since  been 
lifted.  Tougher  guidelines  on  testing  was  imposed  and  the  drug  tests  are  now 
resuming. 

One  provision  of  the  new  guidelines  is  that  the  drug  firm  whose  product  is 
being  tested  agrees  to  assume  legal  liability  for  the  experiment  and  pay  all  costs 
if  anything  goes  wrong. 

While  the  products  of  numerous  drug  firms  have  been  tested  on  Florida  prison- 
ers, only  Parke  Davis  has  conducted  its  own  experiment  during  the  past  two 
years.  Other  firms  used  independent  Florida-based  research  laboratories. 

One  Miami  research  firm.  Peninsular  Testing  Co.,  handled  28  of  the  60  tests 
conducted  during  the  period,  five  more  than  Parke  Davis  performed  with  its 
own  facilities. 

Attorneys  for  the  Department  of  Heatlh  and  Rehabilitative  Services  said  they 
did  not  want  the  use  of  testing  laboratories  to  shield  the  actual  drug  companies 
from  liability  for  their  products.  Thus  the  new  requirement,  whichi  makes  both 
the  testing  lab  and  the  drug  company  pledge  liability. 

Another  provision  of  the  new  regulations  is  that  tests  not  be  made,  except  in 
special  circumstances,  on  institutionalized  juveniles  or  mentally  retarded 
patients. 

Roberts  said  he  imposed  the  moratorium  and  ordered  the  new  regulations  "be- 
cause I  wanted  a  uniform,  departmentwide  policy.  I  also  wanted  to  stop  and 
see  where  we  were  going. 

"We  have  a  real  duty  toward  the  inmates.  We've  become  their  guardians,  and 
that's  a  tremendous  responsibility,"  Roberts  said. 

State  oflBcials  say  the  safety  of  drugs  tests  in  Florida  institutions  is  guaranteed 
because  each  proposed  experiment  must  first  pass  the  scrutiny  of  a  protocol  re- 
view committee,  made  up  of  four  University  of  Florida  medicine  professors  and 
a  layman.  The  committee  has  been  in  existence  since  mid-1971. 

Dr.  Charles  Weiss,  chairman  of  the  committee,  said  his  group  tries  to  meet  at 
least  once  a  month  "to  review  the  safety  and  suitability  of  each  proposed 
experiment." 

Since  the  committee's  inception,  it  has  reviewed  54  proposed  experiments. 
Seven  have  been  rejected,  canceled  or  withdrawn  by  sponsors. 

Prisons  provide  controlled  populations  conducive  to  making  a  number  of  tests, 
Weiss  said.  And  he  said  experimentation  on  humans  is  absolutely  essential  for 
medical  science  to  move  forward. 

In  addition  to  reviewing  all  experiment  proposals,  members  of  the  review 
committee  originate  some  of  them. 

Weiss  himself  conducted  three  experiments  during  the  past  two  years,  includ- 
ing one  he  did  for  Johnson  &  Johnson  among  prisoners  at  the  Lowell  Correctional 
Institution  on  the  safety  of  "No  More  Tangles"  creme  rinse. 

Weiss  said  the  test  of  the  already  marketed  product  was  ordered  by  the  federal 
Food  and  Drug  Administration  to  prove  the  product  was  safe  on  human  scalps. 

He  said  it  is  not  unusual  for  drug  firms  to  approach  members  of  the  committee 


876 

for  an  experimentation  contract  because  most  members  are  research  oriented. 

Weiss,  who  worked  in  clinical  research  for  Parke  Davis  Co.  for  11  years  before 
coming  to  the  University  of  Florida  in  1969,  said  that  whenever  a  committee 
member  himself  plans  to  do  the  research,  he  does  not  vote  to  avoid  the  appearance 
of  a  conflict  of  interest. 

Weiss  said  he  feels  the  committee  would  be  more  effective  if  it  is  also  included 
a  lawyer  and  another  nonmedical  man. 

"It's  a  tough  business,"  he  said.  "My  basic  hope  is  that  we  can  continue  to 
improve  the  quality  of  the  studies,  reduce  risk  at  the  same  time,  and  assure  every- 
one's rights." 

Records  show  three  basic  types  of  drug  experiments  have  been  conducted  re- 
cently in  Florida  prisons :  tests  of  new  and  experimental  drugs ;  safety  tests  of 
pharmaceuticals  already  on  the  market  which  are  usually  ordered  by  FAA ;  and 
tests  of  the  body's  tolerance  to  certain  types  of  already  existing  drugs. 

Inmates  participating  in  the  tests  are  asked  to  sign  consent  forms  which  are 
supposed  to  spell  out  the  purpose  of  the  tests  in  simple  language.  Yet  some  of 
the  forms  contain  passages  such  as :  "I  consent  to  participate  to  medical  re- 
search study  PT-72  to  evaluate  safety  and  tolerance  of  a  new  drug,  RB-K8 
following  an  injection  of  either  0.125  gm,  or  0.75  gm  of  drug  twice  a  day  for  a 
period  of  either  seven  or  10  days." 

Ray  Worley,  chief  of  research  and  statistics  for  the  Division  of  Corrections, 
said  there  have  been  no  major  mishaps  because  of  drug  testing  in  Florida.  But 
he  said  there  have  been  a  number  of  significant  discoveries. 


[From  the  Clearwater  Sun,  Dec.  2&,  1972] 
Money  Said  Main  Reason  Prisoners  Join  Drug  Tests 

(By  TomRaum) 

Raiford,  Fla. — Some  prisoners  may  participate  in  drug  experiments  to 
make  a  contribution  to  society  while  other  do  it  for  the  free  physical  examina- 
tion. But  most  volunteer  solely  for  money,   says  a   state  corrections   oflScial. 

"What  money  an  inmate  gets  out  of  this  program  is  about  all  he  gets,"  said 
L.  E.  Dugger,  superintendent  of  the  Union  Correctional  Institution  at  Raiford. 
"He  really  has  no  other  source  of  income." 

Dugger  said  inmates  use  the  money  to  make  purchases  in  the  canteen  and  to 
send  home  to  their  families.  He  said  strict  procedures  at  the  prison  and  the 
state  level  governing  drug  tests  protect  inmates  from  risking  their  health  solely 
for  monetary  reasons. 

"We  think  we  have  adequate  safeguards,"  said  Dugger. 

Of  the  60  drug  tests  conducted  in  Florida  prisons  in  the  past  two  years,  38 
were  performed  at  Union,  Florida's  largest  state  prison. 

One  of  the  nation's  major  pharmaceutical  firms,  Parke  Davis  Co.  has  a  perma- 
nent experimentation  center  in  a  wing  of  the  prison  hospital,  space  it  leases  from 
the  state. 

Dr.  Meigs  Haggerty,  the  Parke  Davis  representative  here,  agrees  that  few  in- 
mates would  show  up  if  they  weren't  paid. 

Pay  to  inmates  can  vary  widely  depending  upon  the  experiment,  ranging 
from  as  low  as  a  few  dollars  up  to  $200.  Haggerty  said  the  pay  scale  is  based 
"mainly  on  what  we  do  to  each  one." 

"For  instance,  it's  so  much  every  time  they  swallow  a  pill,  and  so  on.  It's  a 
dollar  every  time  a  needle  goes  in,  25  cents  every  time  we  take  a  urine  sample," 
he  said. 

Parke  Davis  and  other  drug  firms  also  pay  prison  hospital  doctors  and  tech- 
nicians— in  some  cases  thousands  of  dollars — for  helping  with  tests  despite  a 
state  ban  on  payments  to  state  employes  that  could  involve  a  conflict  of  interest. 

Only  one  drug  test  is  under  way  in  the  Parke  Davis  compound  now,  involving 
a  new  oral  vaccine  thought  to  be  effective  in  combatting  the  so-called  London  flu. 
Six  hundred  prisoners  are  participating. 

If  it  proves  successful,  said  Haggerty,  "the  vaccine  will  be  on  the  market 
next  year." 

During  the  past  two  years,  inmates  have  tested  cough  syrups,  a  new  rabies 
vaccine,  fly  vaccines,  medicine  for  arthritis,  epilepsy  and  tuberculosis,  a  host  of 
antibiotics  and  pain  killers,  cold  compounds  and  tranquilizers. 


877 

They  subjected  themselves  to  dizziness,  nausea,  vomiting,  intentional  exposure 
to  the  Hong  Kong  flu,  temporary  hearing  losses,  hives  and  considerable  soreness. 

A  moratorium  was  imposed  on  all  drug  tests  last  summer  by  Health  and 
Rehabilitative  Services  Secretary  Emmett  Roberts.  The  moratorium  has  since 
been  lifted.  Tougher  guidelines  on  testing  was  imposed  and  the  drug  tests  are 
now  resuming. 

One  provision  of  the  new  guidelines  is  that  the  drug  firm  whose  product  is 
being  tested  agrees  to  assume  legal  liability  for  the  experiment  and  pay  all  costs 
if  anything  goes  wrong. 

While  the  products  of  numerous  drug  firms  have  been  tested  on  Florida  prison- 
ers, only  Parke  Davis  has  conducted  its  own  experiment  during  the  past  two 
years.  Other  firms  used  independent  Florida-based  research  laboratories. 

One  Miami  research  firm — Peninsular  Testing  Co. — handled  28  of  the  60  tests 
conducted  during  the  period — five  more  than  Parke  Davis  performed  with  its 
own  facilities. 

Attorneys  for  the  Department  of  Health  and  Rehabilitative  Services  said  they 
did  not  want  the  use  of  testing  laboratories  to  shield  the  actual  drug  companies 
from  liability  for  their  products.  Thus  the  new  requirement,  which  makes  both 
the  testing  lab  and  the  drug  company  pledge  liability. 

Another  provision  of  the  new  regulations  is  that  tests  not  be  made,  except  in 
special  circumstances,  on  institutionalized  juveniles  or  mentally  retarded 
patients. 

Roberts  said  he  imposed  the  moratorium  and  ordered  the  new  regulations  "be- 
cause I  wanted  a  uniform,  departmentwide  policy.  I  also  wanted  to  stop  and 
see  where  we  were  going." 

"We  have  a  real  duty  toward  the  inmates.  We've  become  their  guardians,  and 
that's  a  tremendous  responsibility,"  said  Roberts. 

State  officials  say  the  safety  of  drug  tests  in  Florida  institutions  is  guaranteed 
because  each  proposed  experiment  must  first  pass  the  scrutiny  of  a  protocol 
review  committee,  made  up  of  four  university  of  Florida  medicine  professors 
and  a  layman.  The  committee  has  been  in  existence  since  mid-1971. 

Dr.  Charles  Weiss,  chairman  of  the  committee,  said  his  group  tries  to  meet 
at  least  once  a  month  "to  review  the  safety  and  suitability  of  each  proposed 
experiment." 

Since  the  committee's  inception,  it  has  reviewed  54  proposed  experiments. 
Seven  have  been  rejected,  canceled  or  withdrawn  by  sponsors. 

Weiss  defends  drug  testing,  saying  that  for  every  new  drug  "there  has  to  be  a 
first  time  in  humans.  Somewhere,  someplace,  sometime  there  has  to  be  that  first 
step." 

Prisons  provide  controlled  populations  conducive  to  making  a  number  of 
tests,  said  Weiss.  And  he  said  experimentation  on  humans  is  absolutely  es- 
sential for  medical  science  to  move  forward. 

In  addition  to  reviewing  all  experiment  proposals,  members  of  the  review 
committee  originate  some  of  them. 

Weiss  himself  conducted  three  experiments  during  the  past  two  years,  in- 
cluding one  he  did  for  Johnson  and  Johnson  among  prisoners  at  the  Lowell 
Correctional  Instituiton  on  the  safety  of  "No  More  Tangles"  creme  rinse. 

Weiss  said  the  test  of  the  already  marketed  product  was  ordered  by  the 
federal  Food  and  Drug  Administration  to  prove  the  product  was  safe  on 
human  scalps. 

He  said  it  is  not  unusual  for  drug  firms  to  approach  members  of  the  com- 
mittee for  an  experimentation  contract  because  most  members  are  research 
oriented. 

Weiss,  who  worked  in  clinical  research  for  Parke  Davis  Co.  for  11  years 
before  coming  to  the  University  of  Florida  in  1969,  said  that  whenever  a  com- 
mittee member  himself  plans  to  do  the  research,  he  does  not  vote  to  avoid  the 
appearance  of  a  conflict  of  interest. 

Weiss  said  he  feels  the  committee  would  be  more  effective  if  it  also  included 
a  lawyer  and  another  non-medical  man. 

"It's  a  tough  business,"  he  said.  "My  basic  hope  is  that  we  can  continue  U 
improve  the  quality  of  the  studies,  reduce  risk  at  the  same  time,  and  assure 
everyone's  rights." 

Records  show  three  basic  types  of  drug  experiments  have  been  conducted 
recently  in  Florida  prisons :  tests  of  new  and  experimental  drugs ;  safety  tests 
of  pharmaceuticals  already  on  the  market  which  are  usually  ordered  by  FDA ; 
and  tests  of  the  body's  tolerance  to  certain  types  of  already  existing  drugs. 


878 

Inmates  participating  in  the  tests  are  asked  to  sign  consent  forms  which  are 
supposed  to  spell  out  the  purpose  of  the  tests  in  simple  language.  Yet  some  of 
the  forms  contain  passages  such  as :  "I  consent  to  participate  to  medical  re- 
search study  PT-72  to  evaluate  safety  and  tolerance  of  a  new  drug,  RB-K8  fol- 
lowing an  injection  of  either  0.125  gm,  or  0.75  gm  of  drug  twice  a  day  for  a 
period  of  either  seven  or  10  days." 

Ray  Worley,  chief  of  research  and  statistics  for  the  Division  of  Corrections, 
said  there  have  been  no  major  mishaps  because  of  drug  testing  in  Florida.  But 
he  said  there  have  been  a  number  of  significant  discoveries.  For  instance,  he 
said  pioneering  research  was  done  in  the  Florida  prison  system  into  the  use 
of  iodine  to  disinfect  small  water  supplies,  a  procedure  now  used  by  the  Army 
in  Vietnam. 

Advances  have  also  been  made  toward  an  externally  administered  vaccine 
for  gonorrhea  as  a  result  of  experiments  conducted  here  in  1968,  said  Worley. 

And  experiments  on  a  new  rabies  vaccine  less  painful  and  more  effective 
than  former  vaccines  for  the  disease  are  expected  to  bear  fruit  in  the  near 
future,  he  said. 

Senator  Kennedy.  Pharmaceutical  companies  experimenting  pay 
thousands  of  dollars  each  year  to  prison  doctors  and  hospital  super- 
visors who  help  with  the  tests.  Drug  firms  reported  paying  one  hospital 
supervisor  more  than  $7,000  w^hile  he  was  passing  judgment  on  one  of 
their  tests,  State  Corrections  Division  records  show. 

Mr.  Stetler.  That  does  not  seem  like  a  large  amount  over  a  two-year 
period.  You  would  have  to  know  more  than  that  to  pass  judgment  on 
the  arrangement. 

Senator  Kennedy.  Do  you  think  your  company  should  be  paying 
individuals  who  are  going  to  be  making  judgments  on  the  safety  of 
these  tests  ? 

Mr.  Stetler.  You  either  pay  them  or  you  won't  get  anybody  to  get 
the  work  done  for  you.  Incidentally,  they  don't  make  the  final  judg- 
ment, because  the  material  we  get  from  them  and  others  is  all  ulti- 
mately submitted  to  the  FDA. 

Senator  Kennedy.  They  are  not  making  the  judgment  as  to  whether 
it  is  safe  or  not? 

Mr.  Stetler.  They  probably  were  working  in  a  supervisory  capacity 
and  conducted  the  tests.  They  w^ould  give  their  opinion  but  their 
opinion  would  be  only  a  small  factor  in  terms  of  whether  the  drug  was 
ever  accepted  by  FDA. 

Senator  Kennedy.  Still,  as  I  understand  it,  you  distinguish  here 
between  the  researchers  and  the  people  who  are  making  decisions  about 
whether  those  drugs  are  safe  or  not  ?  You  find  out  from  them.  You 
make  payments  to  them  despite  a  State  policy  prohibiting  this?  Do 
you  see  any  conflict  of  interest  here  ? 

Mr.  Stetler.  Obviously,  if  the  man  is  violating  the  law,  he  is  violat- 
ing the  law  and  we  don't  condone  it.  But  in  terms  of  do  we  pay  people 
to  do  work  for  us?  Yes,  we  do. 

Senator  Kennedy.  People  who  make  judgments  on  safety 

Mr.  Stetler.  As  I  say,  I  am  not  familiar  with  that.  If  that  is  a  non- 
scientist  prison  official  and  if  he  is  operating  outside  of  the  law",  we 
have  no  time  for  him.  I  cannot  see  how  lie,  alone,  would  be  making  a 
recommendation  as  to  whether  a  drug  was  safe  but,  as  I  say,  I  don't 
know  that  case. 

Senator  Kennedy.  As  I  understand,  they  have  stopped  all  tests  in 
Florida ;  have  they  ? 

Mr.  Stetler.  No,  I  think  they  are  still  using  prisoners. 


879 

Senator  Kennedy.  I  understand  they  all  did  stop.  Last  summer,  the 
State  Health  Rehabilitation  placed  a  moratorium  on  all  procedures  in 
Florida. 

Mr.  Stetler.  I  know  there  has  been  considerable  testing  in  Florida. 

Senator  Kennedy.  Why  is  that  ?  Are  there  protests  in  other  States 
as  well  as  Florida? 

Mr.  Stetler.  I  didn't  hear. 

Senator  Kennedy.  They  put  a  moratorium — you  said  you  under- 
stood there  were  some  more  protests? 

Mr.  Stetler.  I  said  I  did  not  know  there  was  a  moratorium.  I  didn't 
say  protests.  I  think  someone  mentioned  this  morning,  that  the  Penn- 
sylvania prisons  had  some  sort  of  a  moratorium.  That  is  the  only  one  I 
had  heard  of,  myself. 

Senator  Kennedy.  Senator  Javits,  would  you  like  to  inquire  ? 

Senator  Javits.  Mr.  Stetler,  it  is  a  fact,  is  it  not,  that  the  Phase  I 
studies  follow  animal  studies ;  is  that  correct  ? 

Mr.  Stettler.  Very  extensive  animal  studies. 

Senator  Javits.  1  have,  unfortunately,  been  detained  on  other  mat- 
ters. All  of  us  are  grateful  to  Senator  Kennedy  for  carrying  on  this 
inquiry.  So,  I  have  only  had  the  opportunity  to  read  Miss  Mitford's 
testimony,  but  it  is  very  impressive  and  very  important. 

There  is  a  middle  ground,  is  there  not,  in  this  matter  which  could 
continue  what  you  say  is  necessary  experimentation  with  humans  and 
even  use  the  prisons,  but  with  humanity  and  decency.  The  thing  that 
worries  me — and  that  is  why  I  would  like  you  to  enlighten  us,  if  you 
can — is  two  charges  made  by  Miss  Mitf ord  in  her  testimony. 

One  charge  she  makes  is  that  the  HEW  regulations  requiring  in- 
formed consent — and  I  was  the  author  of  that  amendment  in  the  Sen- 
ate two  years  ago — don't  apply,  she  says,  to  the  private  industry  re- 
search and  that  HEW  does  not  even  maintain  a  list  of  prisoners,  let 
alone  records  of  which  HEW-financed  research  is  in  progress  nor  does 
it  police  the  programs  of  its  own  researchers. 

At  another  point,  she  says,  "Since  the  studies  are  carried  out  in  the 
secrecy  of  prisons,  if  a  volunteer  becomes  ill  or  dies  as  a  result  of  the 
procedures  to  which  he  is  subjected,  it  is  unlikely  that  this  will  ever 
come  to  anybody's  attention." 

Can  you  answer  those  two  charges  ?  The  prisoner  is  a  person  like  you 
and  I,  and  why  shouldn't  all  the  regulations,  all  the  protections,  all 
the  safeguards  apply  to  him,  even  though  he  is  in  prison  ? 

Mr.  Stetler.  As  I  say  in  my  statement,  there  is  no  debate  on  that. 
They  absolutely  should  apply.  At  this  time  we  doubt  the  need  for  addi- 
tional statutory  controls.  Regulatorily  speaking,  the  HEW  and  FDA 
have  good  guidelines.  I  am  not  sure  they  are  fully  enforced  in  some 
places.  Undoubtedly  enforcement  could  be  greatly  improved. 

I  do  not  want  to  sit  here  and  imply  that  we  have  a  calloused  attitude 
about  the  situation  that  exists  in  prisons.  I  am  sure  there  are  bad  things 
that  happen.  The  general  atmosphere  in  which  you  find  these  people  is 
very  bad.  The  conditions  that  cause  them  to  have  the  incentive  to  vol- 
unteer, I  am  sure  in  many  instances,  should  not  exist. 

We  would  be  a  willing  party  to  an  effort  to  correct  these  conditions. 
As  to  whether  bad  results  would  come  to  light,  I  don't  know.  I  cannot 
comment  expertly  on  that. 


880 

I  am  sure  that  the  general  situation  in  many  prisons  is  dismal. 
Nevertheless,  I  personally  think  a  prisoner  can  give  informed  con- 
sent. That  he  is  not  "per  se  locked  out  of  informed  consent  because  he 
is  a  prisoner.  I  think,  however,  there  should  be  no  attempt  to  get  a 
waiver  from  him. 

What  prison  officials  do,  I  am  sure,  varies.  One  thing  I  perceive,  as 
I  have  studied  this  matter  carefully  over  the  last  couple  of  weeks,  is 
that  probably  the  sponsors  of  research  have  a  greater  responsibility 
to  establish  a  continual  monitoring  system,  even  though  an  inde- 
pendent investigator  has  been  hired  to  do  the  job.  I  don't  think  we  can 
delegate  to  an  investigator  all  of  these  elements  that  have  to  be  assured. 
I  think  the  monitoring  has  to  be  more  acute  than  it  has  been  in  the 
past. 

Senator  Javits.  What  about  an  industry  counnittee  to  see  that  this 
whole  matter  is  handled  with  humanity  and  decency  and  that  the  laws* 
are  observed  and  complied  with  ?  You  can  be  very  useful.  I  can  hardly 
conceive  of  a  pharmaceutical  company  that  would  want  the  trade  asso- 
ciation to  come  out  with  a  statement  that  they  are  being  inhumane  to 
the  subjects  of  these  tests. 

I  think  you  have  a  tremendous  sanction  within  the  industry.  Is  there 
anything  like  that  in  offing  ? 

^Ir.  Stetler.  Yes.  I  just  mentioned  at  the  end  of  this  statement  that 
we  have  had  a  discussion  with  the  Council  on  Crime  and  Delinquency. 
We  are  going  to  work  very  soon  with  them  to  investigate  this  entire 
matter.  I  think,  yes,  there  is  a  place  for  a  set  of  specific  guidelines 
which  we  could  promulgate.  Some  things  occur  to  me  right  away.  I 
mentioned  the  monitoring.  I  think  that  is  an  important  factor.  You 
can't  just  delegate  your  responsibility  away. 

I  think  we  should  probably  have  a  A^ery  definite  agreement  with  re- 
spect to  the  written  consent  form,  not  vary  it  in  form  as  they  now  do. 
I  think  we  ought  to  absolutely  outlaw  the  business  of  waivers. 

Another  thing  would  be  to  do  something  to  investigate  the  matter 
of  adequate  compensation.  Admittedly,  that  is  a  touchy  subject.  We 
are  not  trying  to  get  by  with  testing  on  prisoners  at  $1  a  day.  I  think 
we  could  work  out  some  adequate  compensation  with  prison  officials 
bearing  in  mind  the  low  levels  of  compensation  for  all  other  work  in 
prisons. 

I  know  the  officials  of  the  Council  on  Crime  and  Delinquency  are 
worried  about  compensation.  I  mean  compensation  for  prisoners  across 
the  board.  That  would  be  a  part  of  our  discussion. 

Another  thing,  the  present  requirements  mention  a  review  commit- 
tee. That  might  be  more  in  theory  than  in  fact  in  some  prisons.  Our 
guidelines  should  get  to  that  issue  to  insure  that  some  kind  of  an  effec- 
tive review  committee  does  exist. 

Senator  Javits.  Under  those  circumstances,  as  long  as  you  make  all 
those  concessions — which  I  think  are  only  fair — why  object  to  legisla- 
tion which  would  codify  this  responsibility  ? 

Mr.  Stetler.  As  I  said  before,  I  think  we  have  legislative  authority 
with  respect  to  drugs.  There  are  a  lot  of  other  medical  experimenta- 
tions that  are  not  subject  to  the  kind  of  regulations  we  have  in  the 
Food  and  Drug  Act.  But,  as  far  as  drugs  are  concerned,  it  is  more  a 
matter  of  enforcement  than  it  is  of  a  need  for  new  legislation. 


881 

Senator  Javits.  The  prison  population  obviously  changes,  but  the 
overall  number  remains  relatively  constant.  I  think  it  is  somewhere 
between  500,000  and  600,000.  What  percentage  of  a  prison  population 
as  a  constant  is  subjected  to  these  experiments? 

Mr.  Stetler.  Nobody  knows,  but  in  terms  of  the  total  prison  popula- 
tion it  would  be  a  small  percentage.  The  other  question  was,  what  per- 
centage of  our  Phase  I  percentage  involves  prisoners  and  that  is  a  high 
percentage. 

Senator  Javits.  What  percentage  of  your  experimentations  are  with 
humans,  did  you  say  ? 

Mr.  Stetler.  About  70  percent. 

Senator  Javits.  What  percentage — in  your  best  judgment,  or  the 
order  of  magnitude — do  you  call  small  for  the  number  involved  ? 

Mr.  Stetler.  I  am  going  to  say  15  percent  to  20  percent.  That  may 
be  high. 

Senator  Javits.  Even  if  it  were  10  percent,  it  would  still  be  50,000 
or  more  ? 

Mr.  Stetler.  It  is  a  substantial  number  of  people. 

Senator  Javits.  Does  any  State  prohibit  it  ? 

Mr.  Stetler.  I  am  advised  that  Florida  and  Pennsylvania  have 
moratoriums. 

Senator  Javits.  Is  it  an  industry  problem  that  you  feel  this  is  going 
to  be  cut  off? 

Mr.  Stetler.  If  it  were  cut  off,  it  would  be  a  social  and  an  industry 
problem,  because  it  would  have  a  tremendous  effect  on  our  ability  to 
clear  new  drugs  for  the  market. 

Senator  Javits.  Am  I  correct  in  saying  that  the  NIH  is  using  pris- 
oners in  its  work  ? 

Mr.  Stetler.  Absolutely,  the  Government  uses  them. 

Senator  Javits.  'Which  Governmental  institutions  ? 

Mr.  Stetler.  In  all  sorts  of  Government  prisons  and  Government 
products. 

Senator  Javits.  Would  you  give  us  a  percentage  estimate  of  the 
number  of  prisoners  that  are  engaged  in  Government  type  projects? 

Mr.  Stetler.  I  could  say  it  is  a  significant  number,  but  I  couldn't 
estimate  it. 

Senator  Javits.  It  is  significant  ? 

Mr.  Si'ETLER.  Significant. 

Senator  Javits.  Do  you  know  whether  there  are  any  different  condi- 
tions monitoring  for  them  than  the  ones  you  use  ? 

Mr.  Stetler.  Pretty  much  the  same  ones.  The  FDA  has  incorporated 
the  NIH  regulation  guidelines  into  their  guidelines. 

Senator  Javits.  When  you  say  they  are  not  being  enforced,  do  you 
also  include  the  Federal  Government  guides  ? 

Mr.  Stetler.  Oh,  yes. 

Senator  Javits.  That  is  an  important  point.  You  don't  think  they 
are  enforced  in  their  work  any  more  than  they  are  in  yours  ? 

Mr.  Stetler.  No. 

Senator  Kennedy.  Senator  Pell  ? 

Senator  Pell.  I  have  no  questions  at  this  time.  I  apologize  for  my 
lateness,  but  I  was  chairing  another  hearing.  I  would  like  to  commend 
the  Chairman  for  conducting  these  important  hearings. 


882 

Senator  Kennedy.  Mr.  Stetler,  you  can*t  get  away  from  the  fact  that 
even  under  the  Food  and  Drug  Administration,  under  the  regulations, 
if  ihvestigators  are  using  old  drugs  for  new  purposes  as  we  have  heard 
testified  here,  there  is  no  way  possible  the  FDA  is  going  to  be  able  to 
police  that. 

Mr.  Stetler.  No,  the  FDA  is  not  in  a  i:)Osition  to  police  that. 

Senator  Kjennedy.  As  you  have  heard  here,  we  have  got  Avide  use  of 
diethylstilbestrol  across  the  country,  which  has  never  been  approved 
by  the  Food  and  Drug  Administration  for  tlie  reasons  that  they  are 
being  used.  That  is  happening  to  hundreds  of  Americans.  There  is  no 
way  that  the  FDA  under  any  legislative  authority  can  control  that? 
You  are  not  recommending  any  legislative  suggestions  in  order  to  try 
to  s^et  a  handle  on  that  ? 

Mr.  Stetler.  I  should  tell  you  that  to  tliis  point  I  have  not  directed 
anv  of  my  comments  to  that  at  all. 

Senator  Kennedy.  Would  you  want  regulations  on  that? 

Mr.  Stetler.  Let  me  comment  on  that  issue  which  is  really  a  medical 
profession  and  an  FDA  problem.  There  is  a  very  serious  question  as  to 
how  much  or  how  far  the  FDA  is  or  should  be  authorized  to  get  in- 
volved in  the  practice  of  medicine. 

Senator  Kennedy.  We  are  now  talking  about  the  use  of  drugs  for 
purposes  that  they  were  never  authorized  to  be  used  for  by  the  FDA. 

Mr.  Stetler.  I  think  the  problem  is  not  as  large  a  one  as  may  be  in 
the  minds  of  this  committee. 

Senator  Kennedy.  How  do  you  know  ? 

Mr.  Stetler.  I  don't  know. 

Senator  Kennedy.  Wliy  do  you  make  that  assumption  ?  Do  you  have 
any  information  ? 

Ml'.  Stetler.  Yes. 

Senator  Kennedy.  Don't  you  think  we  ought  to  get  it  ? 

Mr.  Stetler.  Yes.  At  the  moment  I  am  just  giving  my  opinion. 

Senator  Kennedy.  We  heard  that  the  drus^  diethylstilbestrol  was 
used  inappropriately  in  university  centers.  It  is  carcinogenic.  You 
don't  have  any  infoiTaation  and  we  liaven't  seen  any.  As  to  the  wide- 
spread use  of  it,  you  just  say  it  is  not  happening. 

Mr.  Stetler.  I  think  it  is  not  as  big  a  problem  as  some  have  indi- 
cated. I  think  it  is  a  problem. 

Senator  Kennedy.  There  is  no  way  that  the  FDA,  as  it  is  presently 
constructed,  can  do  anything  about  experimental  surgery? 

Mr.  Stetler.  Precisely. 

Senator  Kennedy.  Or,  at  the  present  time,  about  the  use  of  policing 
any  kind  of  devices  to  be  used  in  various  research  ?  There  are  no  re- 
quirements now?  Those  HEW  regulations  that  Senator  Javits  has 
referred  to  certainly  didn't  apply  to  that  mill  in  Philadelphia? 

Mr.  Stetler.  We  are  definitely  in  favor  of  device  legislation.  We  are 
on  record  and  we  will  be  for  it  this  year.  It  is  past  due.  Many  of  our 
companies  are  in  the  device  business.  We  think  there  should  be  legisla- 
tion in  that  field.  -     -  : 

Senator  Kennedy.  We  had  testimony  from  the  Upjohn  Company 
actually  shipping  Depo-Provera  to  a  school  which  was  for  the  retarded 
when,  quite  clearly,  \i  had  never  been  authorized  or  approved  for  such, 
use.  Upjohn  said  they  didn't  know  what  it  was  being  used  for  even 
though  they  knew  very  well  they  were  the  principal  producer  of  it. 


883 

There  were  some  1,500  women  involved  in  experiments.  They  kind  of 
washed  their  hands  of  it. 

Part  of  the  point,  as  I  gather  from  what  Senator  Javits  was  talking 
about,  is  the  burden  that  exists  upon  the  trade  industry  to  prohibit 
that.  What  the  head  of  Upjohn  said  was  he  wouldn't  send  it  if  he  knew 
what  was  happening.  Finally  he  said,  "All  right,  we  won't  do  it  any 
more." 

Wliy  did  it  take  a  Congressional  committee  to  get  that  stopped  ? 

Mr.  Stetler.  That  is  a  marketed  authorized  drug  for  another  pur- 
pose. Then  somebody  decides  on  their  own  to  distort  the  use  of  it. 
I  don't  say  the  industry  doesn't  have  a  responsibility  to  keep  their  eyes 
and  cars  open  and  if  they  find  out  it  is  being  abused,  they  certainly 
have  a  responsibility  to  curtail  their  shipments. 

Senator  Kennedy.  The  only  thing  is  that  the  drug  was  authorized  in 
terminal  cancer  cases.  Here  they  were  sending  sizable  quantities  to  a 
school  for  the  mentally  retarded.  What  is  the  responsibility  of  the  drug 
company  or  the  association  in  this  incident  ? 

Mr.  Stetler.  I  am  talking  as  an  official  of  the  association.  It  would 
be  extremely  hard  for  us  to  police  it.  I  have  said  and  I  am  sure  Upjohn 
has  said  that  they  do  think  they  have  a  responsibility  to  have  some 
concern  about  where  their  products  are  going.  They  said  they  w^on't 
ship  it  anymore  now  that  they  know  of  its  improper  use. 

Senator  Kennedy.  Do  you  know  where  these  new  drugs  are  being 
shipped  to?  Is  there  any  collection  of  material  within  the  association 
that  tells  that? 

Mr.  Stetler.  This  was  not  a  new  drug.  It  was  a  new  use  for  which 
an  IND  was  pending. 

Senator  Kennedy.  There  is  no  machinery  to  oversee  that  within 
the  Association  ? 

Mr.  Stetler.  No  ;  there  is  not. 

Senator  Kennedy.  We  want  to  thank  you  for  coming  here  today. 

I  now  order  printed  in  the  record  all  statements  and  miscellaneous 
pertinent  material  submitted  in  conjunction  with  this  hearing. 

[The  information  referred  to  follows :] 


884 
UNIVERSITY  of  PENNSYLVANIA 

PHILADELPHjIA' 19104 


The  Law  School 
3400  Chestnut  Strfeet  March  12,    1973 


Hon.  Edward  Kennedy 
Suite  431 

Senate  Office  Building 
United  States  Senate 
Washington,  D.  C. 


Dear  Senator  Kennedy: 

It  was  a  pleasure  to  participate  in  your  hearings  on  human  experimentation 
this  past  Wednesday.   The  work  your  subcommittee  is  doing  is  vitally  important, 
not  only  in  preparing  information  for  the  legislation  you  may  decide  to 
draft  but  also  in  alerting  the  public  to  the  serious  issues  raised  by  human 
research  and  in  prompting  action  on  the  part  of  the  various  federal  agencies 
involved.   One  result  of  your  hearings  will  be,  I  am  sure,  that  the  Food 
^nd  Drug  Administration  will  take  another  look  at  the  level  of  compliance 
with  its  Institutional  Review  Committee  requirement  and,  1  hope,  will  amend 
the  regulations  so  as  to  require  (as  DHEW  does)  documentation  that  proper 
committee  review  and  approval  has  taken  place.   Indeed,  both  the  FDA  and 
DHEW  should  move  beyond  present  regulations  to  inform  themselves  about  the 
content  of  "Informed  Consent"  forms  and  the  procedures  through  which  they 
are  actually  administered. 

I  thought  your  probing  of  Mr.  Stetler  of  the  PMA  was  particularly 
enlightening.  His  responses  tended  to  obscure  a  nuunber  of  points,  however. 
First,  when  the  question  of  added  costs  of  non-penal  subjects  for  drug 
testing  is  raised,  it  is  well  to  keep  in  mind  that  this  is  a  $8  billion/year 
industry,  which  is  estimated  to  rise  to  $11.4  billion/year  by  1980.   It 
is  not  as  though  one  were  talking  about  Imposing  a  heavy  burden  on  a  poor, 
struggling  scientist. 

Second,  many  physicians  and  pharmacologists  do  not  share  Mr.  Ste tier's 
view  about  the  need  to  conduct  Phase  I  studies  on  "normals,"  While  vaccine 
trials  must,  obviously,  be  done  on  people  who  have  not  previously  been 
naturally  exposed  to  the  disease  in  question,  this  may  not  be  true  for  other 
drugs.  You  might  consider  taking  testimony  in  the  future  on  this  subject 
from  people  who  represent  the  "science"  as  well  as  the  "business"  side  of 
the  drug  industry.  Of  course,  the  use  of  sick  people  as  test  subjects 
raises  ethical  problems  of  its  own. 


885 


Hon.  Edward  Kennedy  2  March  12,  1973 


Third,  one  should  be  cautious  about  accepting  Mr.  Stetler's  statement 
that  prisoners  are  Ideal  subjects  because  their  environment  Is  so  closely 
controlled.   It  Is  necessary  to  take  Into  account  the  amount  of  drug  abuse 
which  occurs  In  prison  (especially  In  pretrial  detention  facilities,  where 
a  good  deal  of  testing  appears  to  be  conducted) ,  the  fact  that  many  prisoners 
are  not  In  the  best  physical  condition  when  they  enter  the  Institution, 
the  fact  that  many  prisoners  do  not  remain  on  a  strict  prison  diet  but 
supplement  their  meals  with  food  purchased  at  the  commissary  (paid  for  with 
funds  earned  as  research  subjects?),  etc.   Non-drug  research  may  also  be 
subject  to  similar  problems,  as  Is  Indicated  by  the  comments  of  Dr.  Lawrence 
Kohn,  concerning  the  Maryland  typhoid  experiments,  quoted  on  page  two  of 
my  supplemental  statement  submitted  at  the  hearing. 

Mr.  Stetler  suggested  that  "self -regulation"  by  drug  companies  was 
appropriate  and  adequate  for  the  problem.   1  wonder  whether  past  actions 
by  the  drug  companies  supports  this  view?  As  Mr.  Lawson  testified. 
Dr.  Albert  Kllgman  (whose  ivy  Research  Labs  conducts  experiments  in  the 
Philadelphia  county  prisons)  was  suspended  by  the  FDA  In  1966.   At  that 
time,  the  drug  companies  expressed  suprlse  and  concern  over  the  suspension 
(which  was  lifted  after  one  month).   Dr.  Frances  Kelsey  of  the  FDA  tells  me 
that  since  1967  eight  investigators  have  been  suspended.  Did  the  drug  companies 
anticipate  any  of  these  eight  suspensions  and  act  to  remove  the  investigators 
prior  to  the  FDA's  announcement?  Have  they  ever  taken  such  action  on  their 
own? 

It  is  unlikely  that  a  drug  company  would  act  against  an  investigator, 
for  a  number  of  reasons.   (1)  The  company  may  be  unaware  of  the  heavy 
volume  of  research  that  the  investigator  is  carrying  on — which  is  one  of  the 
ways  which  the  FDA  is  alerted  to  possible  problems  since  it  is  aware  of 
the  reports  the  investigator  is  turning  in  to  all  his  companies.   (2)   Eco- 
nomically, there  is  little  incentive  for  a  drug  company  to  discontinue  an 
investigator  whose  ethics  or  methods  are  questionable,  since  it  is  likely 
that  such  Investigators  can  provide  their  service  more  cheaply  than  their 
more  scrupulous  and  careful  colleagues. 

One  final  comment  for  the  record,  if  1  may.   In  my  testimony  1 
attempted  to  "correct"  a  statement  made  by  Miss  Aileen  Adams  concerning 
the  FDA's  "monitoring"  of  drug  tests.   Both  Miss  Adams  and  I  had  the  same 
intention,  I  believe:  to  point  out  that  at  present  the  FDA's  staff  is 
unable  to  do  an  adequate  job  of  actually  making  sure  that  drug  trials  are 
properly  conducted.   1  wished  only  to  clear  up  the  impression  which  she 
may  have  created  that  the  FDA  presently  has  the  primary  obligation  to 
"monitor"  the  conduct  of  tests.  As  I  understand  it,  the  term  "monitor" 
describes  an  employee  of  the  drug  company  (either  in-house  or  specially 
retailed  for  the  purpose)  who  is  supposed  to  be  the  liaison  between  the 
company  and  the  investigator,  to  explain  the  way  in  which  the  test  will 
be  run,  to  make  sure  that  the  facilities  are  adequate,  to  acquaint  the 


93-999  O  -  73  -  pt.  3—7 


886 


Hon.  Edward  Kennedy 


March  12,  1973 


the  investigator  with  his  legal  obligations  to  the  subjects »  etc.   (See 
for  example,  21  CFR  S130.3  (a) (5),  which  states  as  a  condition  of  receiving 
an  investigational  new  drug  exemption  that  "The  sponsor  monitors  the  progress  . 
etc. ,  and  FD  Form  1571  which  requires  the  sponsor  (i.e. ythe  drug  company) 
to  submit  a  statement  of  the  qualifications  of  its  monitors.) 

The  FDA  does  try  to  "monitor  the  monitors"  through  its  inspectors, 
who  will  also  occasionally  check  up  on  an  investigator  directly.  This 
monitoring  has  in  the  past  occured,  however,  only  "for  cause"  (i.e. .when 
an  abuse  or  dishonesty  is  brought  to  the  FDA's  attention)  or  when  the  large 
amount  of  research  being  reported  by  a  single  investigator  leads  the  FDA 
to  question  whether  he  can  be  performing  valid  studies.  There  are  only  a 
few  people  assigned  to  this  work,  as  I  understand.  For  actual  investigations, 
the  FDA  officials  in  charge  (Dr.  Kelsey  and  Dr.  Lisook)  must  call  on  the 
400  or  so  field  inspectors,  who  are  also  responsible  for  inspecting  factories, 
checking  the  quality  of  food  found  in  supermarkets,  supervising  the  operation 
of  methadone maintenance  programs,  etc.  The  inspectors  (who  have  a  200-C 
credential  rating)  are  being  given  a  special  six-week  "crash  course"  to 
prepare  them  to  inspect  the  work  of  clinical  investigators.  Your  committee 
might  want  to  give  further  consideration  to  the  question  whether  the  FDA's 
responsibilities  for  actually  monitoring  all  research  (or  random  cases,  as 
the  FDA  may  now  be  preparing  to  do  itself)  would  improve  the  quality  of  the 
research  and  the  care  with  which  it  is  undertaken  or  would  merely  add  further 
and  unnecessary  bureaucracy. 

Incidentally,  you  may  be  interested  to  know  that  the  Wednesday  hearings 
got  a  good  deal  of  coverage  here  in  Philadelphia.  1  am  enclosing  a  copy 
of  an  article  from  the  Daily  Pennsylvanian  that  1  thought  you  would  like  to  see, 
There  is  much  concern  about  prison  research  in  this  state,  and  the  office 
of  the  Attorney  General  has  expressed  interest  in  the  "moratorium"  concept 
which  1  suggested  to  your  committee.  Decisions  on  a  state-by-state  basis 
would  only  serve  to  emphasize  the  need  for  a  uniform  Federal  approach,  1  believe. 

With  best  wishes  to  you  on  this  important  task,  1  am, 

Cordially  yours. 


'/ 


/.■/ 


.'  L. 


'Alexander  M.  Capron 
Assistant  Professor  of  Law 


AMCrccy 
Enclosure 


887 


Legal  Considerations  Affecting  Clinical  Pharmacological  Studies  in  Children* 
Alexander  Morgan  CAPRONt 


The  interplay  of  some  basic  medical,  ethical, 
and  legal  precepts  presents  pediatric  pharmacology 
with  an  important  and  difficult  problem.  For 
scientific  and  legal  reasons,  drugs  must  be  tested 
for  safety  and  efficacy  before  being  regularly 
employed  in  therapy,  and  this  testing  has  to  take 
account  of  relevant  differences  among  groups  of 
prospective  users  based  on  such  population  differ- 
ences as  age,  race,  and  sex  as  well  as  differences  in 
the  manner  in  which  the  drug  will  be  used  within 
each  population  group.  Law  and  medical  ethics 
also  require  that  informed  consent  be  obtained 
from  the  subjects  on  whom  drug  tests  are  con- 
ducted. Hence  if  the  members  of  a  particular 
group-such  as  the  pediatric  age  group— are  inca- 
pable of  giving  informed  consent,  then  drugs 
cannot  be  tested  on  them  or  approved  for  use  in 
their  group. 

How  Real  Is  The  Problem? 

Before  concluding  that  this  syllogism  makes  all 
children  the  "therapeutic  orphans"'  of  our  ex- 
panding pharmacopoeia,  we  may  wish  to  scrutinize 
each  of  the  foregoing  premises  for  its  significance 
and  validity. 

The  Necessity  of  Testing 

Prior  to  1962,  the  Food,  Drug  and  Cosmetic 
Act  set  only  lax  standards  of  safety  for  new  drugs. 
At  that  time,  the  terrible  tragedy  of  the  thalido- 
mide babies  served  to  reveal  the  inadequacy  of  the 
existing  procedures;  the  United  States  avoided  the 
full  impact  of  the  disaster  only  fortuitously. 

In  some  ways,  the  pre- 1962  experience  is  an- 
cient history,  not  worth  recalling.  On  the  other 
hand,  while  the  present  FDA  system  may  cause 
some  problems  it  is  well  to  remember  that  they  are 
of  a  different— and  far  less  injurious-sort  than 
those  iiidicated  by  the  following  description  of  the 
thalidomide  investigation.^ 

"From  the  National  Research  Council  Conference  on 
Pediatric  Clinical  Pharmacology,  Washington.  DC, 
Novembers,  1971. 

'Assistant  Professor  of  Law,  University  of  Pennsylvania, 
Philadelphia,  Pennsylvania. 


"Although  the  drug  never  emerged  out  of  inves- 
tigational status  in  the  United  States,  the  company 
distributed  such  vast  supplies  as  to  raise  serious 
doubt  as  to  whether  the  company  was  'testing'  or 
promoting  the  drug.  The  company  sent  2  1/2 
million  tablets  to  1,267  investigators.  This  supply 
was  so  vast  as  to  be  capable  of  causing  incalculable 
harm  if  the  'investigational'  drug  turned  out  to  be 
hazardous.  .  .  ." 

"Over  and  above  the  peculiar  aspects  of  the 
'test'  already  noted,  the  American  company  gave 
additional  indications  it  was  not  too  interested  in 
'investigational'  reports.  A  manual  which  it  issued 
to  its  detail  men  who  were  to  distribute  the  drug 
for  'investigation'  stated: 

'.  .  .  .the  main  purpose  is  to  establish  local 
studies  whose  results  will  be  spread  among 
hospital  staff  members.  You  can  assure  your 
doctors  that  they  need  not  report  results  if 
they  don't  want  to,  but  that  we,  naturally, 
would  like  to  know  of  their  results.  Be  sure 
to  tell  them  that  we  may  send  them  report 
forms  or  reminder  letters  but  these  are  ' 
strictly  reminders  and  they  need  not  reply. ' 
"The  manual  added : 

'Tell  the  doctor  that  present  plans  call  for 
Kevadon^to  be  marketed  early  in  1961.  Let 
them  know  the  basic  clinical  research  on 
Kevadon  has  been  done.  Don't  get  involved 
by  selling  a  basis  [sic]  clinical  research  pro- 
gram instead  of  Kevadon.  Appeal  to  the  • 
doctor's  ego- we  think  he  is  important 
enough  to  be  selected  as  one  of  the  first  to 
use  Kevadon  in  that  section  of  the  country. ' 

"It  may  be  noted  that  the  company's  apparent 
disinterest  in  reports  may  have  contributed  to  the 
'investigators'  disinterest  in  reporting. 

"Of  the  1,267  doctors  who  received  the  drug, 
only  276  gave  written  reports  to  the  manufacturers; 
102  doctors  gave  verbal  reports.  . . ." 

"Hundreds  of  'investigators'  failed,  contrary  to 
the  traditions  of  science,  to  keep  adequate  records. 
They  did  not  know  which  patient  they  had  given 
the  drug  to,  at  what  dosage,  or  when. 

"One  result  was  that  later  on,  when  the  hazards 
became  known,  the  investigators  were  uruble  to 
contact  the  patients. 

"Many  doctors,  however,  did  not  contact  the 
patients  even  though  they  did  keep  the  patients' 
name  and  address.  An  FDA  survey  concluded  that 
259  of  1,258  M.D.s  interviewed  took  inadequate 


141 


888 


142 


CLINICAL  RESEARCH 


steps  to  contact  patients  who  had  been  given  the 
drug.  Many  of  the  259  physicians  felt  that  such 
action  was  unnecessary  because  of  the  length  of 
time  that  had  passed  since  the  patient  was  given  the 
drug;  others  had  no  records  indicating  which  of 
their  patients  had  received  the  drug. 

"The  same  FDA  survey  revealed  that  more  than 
half  of  the  physicians  interviewed  had  no  record  of 
the  quantities  of  the  drug  returned  or  destroyed, 
pursuant  to  the  manufacturer's  instructions. 

"Thalidomide  had  not  been  tested  either  abroad 
or  in  the  United  States  in  animals  for  the  possibility 
that  it  might  have  a  harmful  effect  on  the  embryo 
or  fetus.  This  was  despite  the  fact  that,  for  years,  it 
had  been  known  that  (a)  some  drugs  could  cause 
deformities  in  newborn  infants,  and  (b)  the  drug  by 
its  very  nature -a  sedative -was  of  a  type  which 
might  be  used  by  many  pregnant  women. . ." 

"The  savings  in  life  and  economic  resources 
from  a  safe  and  effective  drug  are  often  incalcu- 
lable. But,  conversely,  the  cost  of  an  unsafe  drug 
can  be  astronomic. 

"The  reporter  who  'broke'  the  thalidomide 
story,  Morton  Mintz,  later  wrote:  'Suppose  the 
FDA  medical  officer  had  been  someone  more  'rea- 
sonable' than  Dr.  Kelsey?';  ie,  suppose  thalidomide 
had  been  cleared  for  marketing  in  the  United 
States?  He  answered  the  question:  'If  Dr.  Kelsey 
had  approved  the  thalidomide  application  in  Feb- 
ruary 1961,  five  months  after  its  submission,  an 
estimated  10,000  terribly  deformed  American 
babies  might  have  been  conceived  before  the  drug 
likely  would  have  been  withdrawn  from  use. 

'For  each  of  these  children,  economists  calcu- 
late, the  average  lifetime  cost  of  medical  treatment, 
together  with  the  reduction  in  normal  earning 
power,  would  have  amounted  to  around  $300,000, 
for  a  grand  total  of  $3  billion.'  " 

The  attention  thus  focused  on  drug-testing 
procedures  led  to  the  Kefauver-Harris  amendment 
to  the  Act  which  requires  that  an  appHcant  for 
approval  of  a  new  drug  submit  "full  reports  of 
investigations  which  have  been  made  to  show 
whether  or  not  such  drug  is  safe  for  use  and 
whether  such  drug  is  effective  in  use,"  and  that 
only  drugs  which  prove  to  be  safe  and  effective 
will  be  approved.^  Acting  pursuant  to  this  statute, 
the  FDA  has  promulgated  an  elaborate  set  of  regu- 
lations to  govern  the  testing  of  new  drugs,  covering 
everything  from  periodic  reporting  to  peer  group 
review  to  the  color  of  the  binders  in  which  drug 
applications  must  be  submitted.  Whatever  com- 
plaints one  may  have  with  the  specifics  of  the 
FDA's  three-phase  system,  it  is  fair  to  say  that  the 
law  in  this  case  reflects  the  consensus  of  the  med- 
ical and  scientific  communities  that  adequate  phar- 


macological testing  is  necessary  if  physicians  and 
patients  are  to  prescribe  and  use  drugs  with  con- 
fidence. 

Separate  Tests  for  Each  Group 

Children  cannot  be  regarded  simply  as  "little 
people"  pharmacologically.  Their  metabolism, 
enzymatic  and  excretory  systems,  skeletal  devel- 
opment and  so  forth  differ  so  markedly  from 
adults'  that  drug  tests  for  the  latter  provide  inade- 
quate information  about  dosage,  efficacy,  toxicity, 
side  effects,  and  contraindications  for  children.'  '* 
As  Dr.  Jean  Lockhart  has  stated: 

"The  penalty  for  ignoring  [the]  special  consider- 
ations [which  determine  choice  of  drug  and  drug 
dosage  in  children]  may  be  lack  of  therapeutic 
response  on  the  one  hand  or,  on  the  other,  severe, 
drug-induced  adverse  reactions.  The  'gray  syn- 
drome,' probably  the  most  striking  example  of  the 
latter,  is  believed  caused  by  the  failure  of  the  im- 
mature liver  to  conjugate  free  chloramphenicol  to 
its  glucuronide  and  failure  of  the  kidneys  to  rapidly 
excrete  the  free  chloramphenicol.  Novobiocin  has 
been  shown  to  produce  hyperbilirubinemia  in  neo- 
nates, presumably  due  to  a  conjugation  defect. 
Qiloroanilines  absorbed  through  the  skin  of  new- 
borns in  hospital  nurseries  have  caused  methemo- 
globinemia."' 

The  Food  and  Drug  regulations  reflect  this 
scientific  premise  by  requiring  that  drug  labeling 
"prescribe,  recommend  or  suggest  its  use  only 
under  the  conditions"  for  which  it  has  been  tested 
and  approved.* 

Testing  Requires  "Informed  Consent" 

For  physicians,  the  phrase  informed  consent 
probably  conjures  up  the  image  of  a  cumbersome, 
uimecessary  formality  (the  signing  of  a  printed 
Informed  Consent  Form)  and  brings  to  mind  the 
disastrous  consequences  for  physicians  (and  their 
insurance  carriers)  when  this  legal  formality  has 
not  been  observed.  Yet,  behind  the  informed  con- 
sent rule  lies  a  fundamental  tenet  of  our  society: 
belief  in  the  concept  of  individual  self-determina- 
tion regarding  any  interferences  with  one's  bodily 
integrity.  In  recent  years,  the  courts  have  com- 
bined the  requirement  of  intentional  choice  with 
the  requirement  of  disclosure  as  they  have  come  to 
recognize  that  the  relationship  of  physician  and 
patient  makes  it  incumbent  on  the  professional  to 
inform  the  layman  fully  if  the  latter  is  to  take  an 
active  role  in  making  the  decision  which  nominally 
has  always  been  his  to  make.  The  evolution  of  the 


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LEGAL  CONSIDERATIONS  IN  CHILD  STUDIES 


143 


law  has  thus  placed  on  the  physician  the  unaccus- 
tomed and  difficult  duty  "to  disclose  and  explain 
to  the  patient  as  simply  as  necessary  the  nature  of 
the  ailment,  the  nature  of  the  proposed  treatment, 
the  probability  of  success  or  of  alternatives,  and 
perhaps  the  risks  of  unfortunate  results  and  un- 
foreseen conditions."'  While  this  obligation  may 
always  seem  time-consuming  and  frequently  waste- 
ful, it  only  serves  to  underscore  the  basic  concern 
of  society  that  so  far  as  is  possible  individuals  be 
exposed  only  to  those  risks  which  they  have  volun- 
tarily chosen  for  themselves.  Our  emphasis  on 
consent  reflects  not  only  solicitude  for  individual 
human  integrity  but  also  a  desire  to  educate  indi- 
viduals about  the  burdens  and  costs  inherent  in  the 
making  of  choices. 

In  certain  circumstances,  the  law  deviates  from 
the  requirement  of  consent,  either  by  presuming  it 
to  exist  (for  emergency  treatment)  or  by  allowing 
a  guardian  to  substitute  his  approval  for  that  of  a 
person  who  is  physically  or  mentally  incapable  or 
legally  incompetent  to  give  consent.  It  is  by  the 
latter  means,  of  course,  that  physicians  routinely 
get  permission  for  therapeutic  interventions  in 
children  who  are  too  young  to  consent.  This  does 
not  help  us  with  our  difficulty,  however,  since 
authoritative  commentators  such  as  Sir  Harvey 
Druitt,  KCB,  author  of  the  legal  views  expressed  in 
the  British  Medical  Research  Council's  Responsi- 
bility in  Investigations  on  Human  Subjects,  are  of 
the  opinion  that 

"the  parent  has  no  legal  authority  to  consent  to 
medical  procedures  being  carried  out  on  his  child 
for  the  advancement  of  scientific  knowledge  or  for 
the  benefit  of  humanity,  if  those  procedures  'are  of 
no  particular  benefit  to'  the  child  and  'may  carry 
some  risk  of  harm.'  ""' 

Professors  Henry  Beecher  and  William  Curran 
of  Harvard  Medical  School  argue  vigorously  that 
this  overstates  the  actual  rule,  and  that  American 
statutes,  medical  codes,  and  cases  permit  parents 
to  give  consent  for  medical  interventions  of  no 
direct— and  in  some  instances,  no  indirect -heneVit 
to  their  child.  This  is  certainly  one  reading  of  the 
leading  case  in  this  area,  Bonner  v.  Moran. ' '  The 
trial  court  had  told  the  jury  in  Bonner  that  it 
could  find  that  no  parental  approval  was  necessary 
for  the  15-year-old  plaintiff  to  have  given  valid 
consent  to  donate  a  skin  graft  to  his  cousin  if  he 
was  "capable  of  appreciating  the  nature,  extent 
and  consequences  of  the  invasion"  (as  phrased  by 


the  Restatement  of  Torts).  The  jury  found  for  the 
doctor-defendant,  and  on  appeal  the  court  re- 
versed. It  held  that  the  consent  of  an  "immature 
colored  boy"  was  not  sufficient  for  an  operation 
on  himself  that  was  not  for  his  benefit  and  that 
was  "so  involved  in  its  technique  as  to  require  a 
mature  mind  to  understand  precisely  what  the 
donor  was  offering  to  give."*^  The  case  was  re- 
turned to  the  lower  court  for  a  retrial  in  which  the 
jury  was  to  be  instructed  that  the  surgeon  was 
liable  unless  the  boy's  mother  had  given  her  con- 
sent, directly  or  by  implication. 

Beecher  and  Curran  argue  that  "the  case  does 
not  hold  that  medical  procedures  cannot  be  per- 
formed on  minors  where  there  is  no  direct  benefit 
to  them.  On  the  contrary,  it  holds  that  such  pro- 
cedures can  be  legally  permitted  as  long  as  the 
parents  (or  other  guardians)  consent  to  the  pro- 
cedure."'°  This  casts  more  weight  onto  the 
opinion  than  it  can  bear.  The  actual  ground  for  the 
overruling  is  arguably  that  the  boy  was  simply  too 
immature  to  understand  the  complications  in- 
volved, with  the  issue  of  there  being  no  benefits  to 
the  boy  thrown  in  as  a  mere  addition.  The  reasons 
that  the  mother  might  have  consented -the  news- 
paper acclaim  and  scholarship  donations— apply 
equally  to  show  that  there  were  benefits  to  the 
boy.  Moreover,  the  case  is  really  one  of  apparent 
ratification  of  the  consent  of  a  youngster,  rather 
than  of  someone  else  making  the  choice  instead  of 
his  making  it.  The  Bonner  court  nowhere  suggests 
that  a  parent  has  independent  authority  to  give 
consent  for  a  "nonbeneficial"  intervention  in  a 
child  who  is  too  young  to  give  any  consent  or  who 
opposes  the  intervention.  This  question  remains 
unsettled. 

In  other  words,  Bonner  is  less  than  definitive, 
and  its  singularity  only  emphasizes  that  courts 
have  otherwise  gone  out  of  their  way  to  avoid 
having  to  rule  on  this  question.  At  first  it  appeared 
that  some  light  would  be  shed  on  this  issue  by  the 
disposition  of  court  petitions  in  Massachusetts  in 
the  1950s  requesting  permission  for  the  transplan- 
tation of  a  kidney  from  a  healthy  child  to  his 
ailing  twin.  Peter  Bent  Brigham  Hospital  sought 
declaratory  judgments  in  a  series  of  such  cases 
because  its  attorneys  advised  that  the  parents 
could  not  "legally  consent  to  said  operation  be- 
cause it  is  an  invasion  of  the  person  of  [the  well 
twin]  which  is  allegedly  not  for  his  benefit."" 
The  court,  aided  and  abetted  by  the  lawyers  and 


890 


144 


CLINICAL  RESEARCH 


physicians  involved,  avoided  this  issue,  however, 
by  finding  that  the  donor  would  benefit  from 
losing  a  kidney  because  "the  risk  of  emotional 
•  disturbance  [from  loss  of  his  twin  would]  be 
reduced."  The  court  went  so  far  as  to  rule-after 
shifting  the  ultimate  decision  as  to  risks  and  bene- 
fits back  onto  the  physicians  "if  [they]  decide  to 
perform  the  operation"— that  the  operation  was 
"necessary  to  [the  well  twin's]  future  welfare  and 
happiness."  A  similar  result  was  reached  in  Strunk 
V.  Strunk,^*  in  which  the  court  held  (1)  that  it 
must  deal  with  the  personal  affairs  of  a  27-year-old 
ward  of  a  state  hospital  who  had  an  I.Q.  of  35  "in 
the  same  manner  as  [he]  would  if  he  had  his  fac- 
ulties," and  (2)  that  in  the  exercise  of  this  judg- 
ment, it  was  in  his  "best  interest"  to  donate  a 
kidney  to  his  ailing  28-year-old  brother  to  avoid 
what  a  psychiatrist  predicted  would  otherwise  be 
"an  extremely  traumatic  effect  upon  him"  were 
the  brother  to  die. 

Consequently,  despite  the  almost  unquestion- 
able validity  of  the  premise  that  informed  consent 
is  necessary  for  drug  testing  in  adults,  in  the  case 
of  pediatric  experimentation  the  role  and  function 
of  informed  consent  need  to  be  re-evaluated. 
Rather  than  undermining  the  rule  by  degree, 
through  increasing  the  scope  of  exceptions,  or  by 
neglect,  through  allowing  experimentation  to 
occur  in  "inconspicuous"  places  such  as  state-run 
institutions,  1  would  have  us  inquire  whether  there 
are  other  means  of  safeguarding  the  interests 
which  the  consent  requirement  is  designed  to  pro- 
tect and  then  analyze  who  should  participate  in 
the  exercise  and  review  of  whatever  means  are 
devised. 

Minors*  Inability  to  Consent 

To  the  three  major  premises  there  needs  only 
be  added  the  minor  premise-that  children  are 
incapable  of  giving  valid  consent— for  the  conclu- 
sion to  follow  that  no  new  drugs  can  be  approved 
for  use  in  this  group.  This  minor  premise  (which 
was  assumed  in  much  of  the  preceding  discussion) 
hardly  needs  elaboration.  There  is  no  certain  age  at 
which  children  (often  called  infants  or  minors  by 
the  law)  are  old  enough  to  give  binding  consent. 
The  common  law  fixed  the  age  at  21,  but  that  has 
been  modified  by  statutory  as  well  as  common  law 
exceptions.*^  The  American  Law  Institute,  in 
Section  59  of  its  Restatement  of  the  Law  of  Torts, 
presents  this  as  a  question  of  fact  rather  than  law: 


"If  a  child.  .  .is  capable  of  appreciating  the 
nature,  extent  and  consequences  of  the  invasion, 
his  assent  prevents  the  invasion  from  creating  lia- 
bility, though  the  assent  of  the  parent,  guardian  or 
other  person  is  not  obtained  or  is  expressly 
refused." 

Two  results  may  follow  from  a  drug  being  la- 
belled Not  to  be  used  in  children  or  Ginical  stud- 
ies have  been  insufficient  to  establish  recommen- 
dations for  use  in  infants  and  children.  First, 
physicians  may  prescribe  the  drug  despite  the 
warning.  Although  this  action  violates  the  basic 
premise  of  our  discussion  (that  drugs  must  be 
tested  in  a  group  before  being  used  to  treat  mem- 
bers of  the  group),  this  procedure  is  not  unlawful 
in  any  criminal  or  regulatory  sense.  The  FDA  re- 
quires drug  manufacturers  to  file  applications 
before  distributing  a  drug  for  use  in  an  untested 
manner,  but  its  regulatory  hand  does  not  reach 
into  the  physician's  office  at  present.  The  major 
restraint  on  the  use  of  nonapproved  drugs  is,  of 
course,  the  physicians'  potential  tort  liability. 

The  second  possible  result  is  that  drugs  which 
are  not  approved  for  use  in  children  will  not  be 
prescribed  for  them.  Although  this  result  avoids 
the  hazards  associated  with  the  previous  alterna- 
tive, it  is  viewed  as  unfair  in  the  medical  Uterature, 
presumably  because  some  children  will  be  denied 
treatment  which  will  do  them  more  good  than 
harm  and  might  even  save  their  lives.  Although  I 
am  in  no  position  to  challenge  this  hypothesis,  I 
should  like  to  question  it.  In  other  words,  while 
one  must  agree  that  the  problem  at  hand  is  a  gen- 
uine one  (this  flows  ineluctably  from  the  validity 
of  the  premises),  care  is  needed  in  defining  the 
problem's  dimensions. 

A  Model  of  Successive  Approximations 

It  may  be  possible  to  get  a  handle  on  the  issue 
confronting  us  by  employing  a  model  of  successive 
approximations.  Since  the  nature  of  the  problem 
probably  prevents  one  from  ever  arriving  at  an 
ideal  solution  which  fits  within  all  the  foregoing 
premises  and  yet  avoids  their  conclusion,  the  best 
solution  may  be  simply  to  limit  the  problem  by 
stages  rather  than  to  attempt  an  end  run  which 
requires  an  arbitrary  abandonment  of  the  premises 
themselves. 

Limiting  the  Perceived  Need 

As  a  first  limitation,  reconsider  the  question 
posed  earlier:  how  many  drugs  are  there  which  are 


891 


LEGAL  CONSIDERATIONS  IN  CHILD  STUDIES 


145 


not  approved  for  use  in  children,  yet  which  appear 
able  to  offer  a  significant  improvement  in  the 
treatment  of  a  disease  or  disorder  occurring  in 
childhood?  The  need  for  a  new  drug  must  be 
appraised  very  critically  before  it  is  tested  in  chil- 
dren. For  example,  one  must  ask  just  how  serious 
is  the  condition  in  question  if  allowed  to  run  its 
course  or  if  treated  in  the  presently  accepted 
manner?  Is  the  new  drug  necessary  if  it  offers 
(merely)  a  more  complete,  a  swifter,  a  less  painful, 
or  a  cheaper  cure  than  is  possible  now?  Is  there  a 
need  (in  terms  of  numbers  affected  and  severity  of 
the  affect)  to  test  the  drug  immediately,  or  could 
tests  in  children  be  postponed  until  more  is  known 
about  the  drug's  effects  or  until  our  knowledge  of 
the  human  system  gives  medicine  the  tools  to 
simulate  a  child's  reaction  to  a  drug  by  use  of  a 
computer? 

Limiting  Risks 

Once  the  category  of  drugs  at  issue  has  been 
narrowed,  the  risks  of  each  must  be  evaluated. 
While  it  is  doubtful  that  it  would  be  possible  to 
state  an  across-the-board  level  of  risk  which  could 
be  applied  in  all  situations,  certain  steps  can  be 
taken  to  limit  risks.  Most  fundamentally,  in  addi- 
tion to  thorough  animal  testing,  I  would  suggest 
that  a  drug  should  not  be  tested  in  children  unless 
it  has  been  approved  for  use  in  adults  or  (when  the 
disease  in  question  does  not  occur  in  adults)  has 
been  investigated  for  toxicity,  side  effects  and 
contraindications  through  extensive  Phase  One- 
type  testing  in  adult  volunteers.  References  in  the 
medical  literature  to  a  "reluctance  to  test  drugs  in 
children"''  appear  to  reflect  this  same  concern  that 
children  be  exposed  only  to  the  most  limited  of 
risks.  This  is  one  area  in  which  peer  group  review 
committees  can  play  a  very  positive  and  important 
role. 

Limiting  the  Participants 

As  with  the  questions  of  need  and  risks,  the 
question  "who  should  participate  in  drug  tests?" 
must  be  answered  on  two  levels.  First,  one  has  to 
formulate  general  rules  about  the  categories  of 
subjects  who  are,  and  are  not,  acceptable  experi- 
mental subjects.  Then  there  must  be  mechanisms 
(ie,  people  and  institutions  operating  according  to 
certain  rules)  to  choose  individual  subjects  by 
applying  the  formulations  to  the  groups  in  ques- 
tion.  Here   we   find    ourselves  facing  again  the 


toughest  hurdle  on  the  course:  the  need  to  choose 
subjects  for  experimentation  from  among  a  group 
whose  members  are  incapable  of  volunteering 
themselves.  While  the  previous  limiting  steps  may 
have  made  approaching  the  hurdle  a  little  easier 
than  it  might  otherwise  have  been,  they  have  not 
removed  it.  Yet,  as  I  have  undoubtedly  made 
amply  clear,  I  do  not  see  any  legitimate  way 
around  this  obstacle. 

As  one  way  of  finessing  the  problem,  some 
have  suggested  that  only  Phase  Two  and  Three 
tests  (on  sick  children)  but  not  Phase  One  tests  (on 
normal  children)  be  conducted.^'* ^  This  alterna- 
tive raises  a  number  of  questions,  however.  First, 
would  the  outcome  of  such  a  procedure  be  an 
adquate,  well-controlled  study  as  required  by  the 
FDA?  There  are  sound  scientific  reasons  for  con- 
ducting Phase  One  investigations,  to  determine  a 
drug's  pharmacological  and  toxicological  effects, 
free  of  the  complications  imposed  by  disease; 
there  may  also  be  need  to  conduct  placebo  studies. 
If  the  absence  of  such  steps  reduced  the  certainty 
of  efficacy  and  safety,  this  added  risk  factor  must 
be  recognized  as  an  additional  cost  which  has  been 
assumed  because  normal  testing  procedures  have 
not  been  followed.  This  leads  to  a  second  ques- 
tion: is  it  proper  to  place  additional  risks  (in  drug 
testing  and  use)  on  sick  children?  A  yes  answer  to 
this  question,  if  carried  to  its  logical  end,  would 
suggest  that  drugs  should  be  tested  only  on  the 
basis  of  need  for  an  individual  child,  without 
formal  approval  (basically  the  present  state  of 
affairs,  which  is  seen  as  needing  repair).  Third,  has 
the  dilemma  of  using  children  for  "nonbeneficial" 
research  actually  been  avoided?  Even  with  sick 
children,  certain  procedures  (from  placebo  studies 
to  various  evaluations  of  the  experimental  drug's 
effect)  may  not  be  of  any  direct  benefit  to  the 
patient-subject;  we  are  still  likely  to  be  left  with  a 
number  of  situations  in  which  some  testing  will  be 
necessary  although  not  beneficial  to  the  pediatric 
patient-subjects  involved. 

Who,  then,  should  participate  in  these  studies? 
First,  a  limitation:  no  studies  should  be  done  on 
institutionalized  subjects  or  on  other  subjects 
whose  freedom  is  severely  limited  (unless  the  dis- 
ease or  disorder  occurs  only  in  these  subjects).  The 
reasons  for  this  restriction  seem  obvious;  the  an- 
nals of  medicine  are  replete  with  examples  of  the 
ways  in  which  concern  over  risks  and  respect  for 
the  subject  as  a  human  being  slowly  erode  when 


892 


146 


CLINICAL  RESEARCH 


investigators  rely  on  this  class  of  subject.  While  the 
experiments  in  the  Nazi  concentration  camps 
epitomize  this  phenomenon,  there  are  other  less 
flagrant  examples  which  occurred  prior  to  the 
German  experience  and  which  continue  to  occur.'  ' 
Recent  examples  are  the  study  of  hepatitis  which 
has  been  carried  out  on  mentally  retarded  children 
for  the  past  15  years  at  the  Willowbrook  State 
School  in  Staten  Island,  New  York,**"^°  and  the 
study  on  untreated  syphilis  carried  out  by  the 
Public  Health  Service  since  the  1930s  in  Tus- 
keegee,  Alabama.^  *  Moreover,  if  consent  is  to  play 
a  role  in  the  selection  mechanism,  the  representa- 
tives of  children  under  physical,  mental,  or  eco- 
nomic constraint  are  poorly  positioned  to  exercise 
unfettered  choice. 

Accepting  this  broad  limitation,  what  means  are 
available  for  selecting  participants? 

l.  Selection  by  Guardian 

As  was  previously  stated,  the  present  means  of 
choosing  subjects  operates  on  a  variation  of  in- 
formed consent  model  in  which  the  child's  guard- 
ians (usually  his  parents)  are  said  to  exercise  their 
power  of  consent  for  him.  This  preserves  some  of 
the  intent  of  the  informed  consent  system,  in  that 
the  person  given  the  power  is  one  who  presump- 
tively understands  and  identifies  with  the  child 
and  can  therefore  be  expected  to  act  so  as  to  pro- 
tect him  in  a  manner  similar  to  the  one  which  he 
would  himself  have  chosen.  Nevertheless,  the  fun- 
damental purpose  of  informed  consent-to  assure 
that  one  suffers  only  those  risks  he  has  chosen- is 
not  met  by  substituted  consent,  and  it  would  be 
well  to  end  the  charade  of  consent  (implying  self- 
choice)  for  children's  participation  in  research  and 
to  speak  instead  oi  selection  or  the  like. 

One  result  of  this  perspective  is  to  highlight  the 
fact  that  putting  this  power  of  selection  in  parents, 
as  we  now  do,  is  as  much  a  matter  of  history  or  of 
convenience  as  it  is  a  matter  of  principle.  There  are 
any  number  of  explanations  for  this  societal  allo- 
cation of  authority:  respect  for  the  family  and  a 
desire  to  foster  the  diversity  which  it  brings;  the 
fitness  of  giving  the  power  to  decide  to  the  same 
people  who  created  the  child  and  have  the  duty  to 
support  and  protect  him;  the  belief  that  a  child 
cannot  be  much  harmed  by  parental  choices  which 
fall  within  the  range  permitted  by  society  and  a 
willingness  to  bear  the  risks  of  harm  this  allocation 
entails  or  a  belief  that  in  most  cases  "harm"  would 


be  hard  for  society  to  distill  and  measure  anyway; 
or  simply  the  conclusion  that  the  administrative 
costs  of  giving  authority  to  anyone  but  the  parents 
outweigh  the  risks  for  children  and  for  society 
unless  the  parents  are  shown  to  be  unable  to  exer- 
cise their  authority  adequately.  While  the  au- 
thority assigned  parents  may  be  framed  in  terms  of 
a  right  on  their  part,  such  right  is  far  from  abso- 
lute, howsoever  it  may  be  justified  in  terms  of  the 
foregoing  or  other  rationales. 

Even  if  society  continues  to  assume,  as  a  gen- 
eral rule,  that  parents  are  the  best  (in  whatever 
sense)  representatives  of  their  children,  it  may 
wish  to  place  certain  checks  on  their  decisions— for 
example,  by  inquiring  into  the  grounds  for  the 
decisions.  The  common  law  had  the  habit  of 
taking  things  at  face  value,  and  it  seldom  probed 
the  background  of  a  decision  or  agreement,  much 
less  the  parties'  states  of  mind.  Depending  on  the 
type  of  experiment  for  which  the  child  is  being 
volunteered,  properly  trained  personnel  should  be 
employed  to  analyze  the  basis  of  the  parents'  de- 
cision and  their  motivation  so  as  to  rule  out  cases 
in  which  the  decision  was  made  on  a  faulty  basis, 
with  a  desire  to  punish  or  hurt  the  child,  or  with 
other  pathological  intent.  So  as  to  prevent  the 
spectacle  of  pharmacologists  exploiting  the  eco- 
nomic deprivation  (and  even  desperation)  which 
occurs  in  our  country,  no  economic  incentives 
should  be  attached  to  the  system  of  parental 
choice,  or  any  incentives  should  be  graduated  to 
make  them  "wealth-neutral"  (a  very  difficult 
task).  A  further  danger  in  using  a  system  of  selec- 
tion based  on  economic  rewards  is  that  "the  mar- 
ket" in  this  situation  does  not  behave  according  to 
standard  theory  because  parents'  responsiveness  to 
a  monetary  incentive  is  based  on  their  own  relative 
need  for  money,  which  (in  the  usual  market  ra- 
tionale) is  said  to  reflect  society's  valuation  of 
their  worth,  yet  cannot  similarly  be  said  to  reflect 
society's  valuation  of  the  child-subject. 

2  Selection  on  Basis  of  Fitness 

It  is  also  possible  that  other  persons,  perhaps 
those  who  work  with  large  numbers  of  children, 
would  make  good  selectors  for  experimentation. 
While  it  would  be  difficult  to  assure  that  such  per- 
sons would  act  with  the  level  of  concern  and  atten- 
tion which  is  normative  in  the  parent-child  rela- 
tionship, their  greater  familiarity  with  children 
might  make  them  more  perceptive  in  identifying 


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LEGAL  CONSIDERATIONS  IN  CHILD  STUDIES 


147 


those  who,  for  physiological  or  psychological 
reasons,  would  be  best  suited  for  testing.  It  would, 
of  course,  be  possible  to  use  this  method  in  con- 
junction with  the  method  of  monitored  parental 
selection  previously  set  forth.  Those  charged  with 
making  the  decisions  could  be  individuals  or 
groups  with  varying  representation,  depending  on 
the  expertise  that  was  sought.  Their  determina- 
tions of  fitness  could  be  stated  in  summary  form, 
or  through  an  open,  pubHc  process.  Provided  that 
public  confidence  existed  for  the  grounds  on 
which  the  decisions  were  to  be  made  and  for  the 
integrity  of  the  decision-makers— and  given  both 
the  significance  and  distasteful  nature  of  the 
decisions,  this  is  a  large  assumption— it  would 
probably  make  little  difference  whether  the  delib- 
erations were  public  or  private,  since  the  final 
outcome  would  contain  the  value  judgments  which 
inhere  in  the  system  as  to  who  is  a  proper  experi- 
mental subject.  This  "rational"  process  differs 
from  the  processes  of  juries  and  draft-boards, 
who  operate  with  broad  discretion  and  need  not 
provide  "reasons"  for  their  decisions;  the  revela- 
tion of  their  processes  would  probably  disturb  the 
public  by  making  clear  the  value-laden  grounds  on 
which  they  act.** 

3.  Random  Choice 

If  we  are,  in  fact,  speaking  of  a  definable  group 
and  if  all  members  of  the  group  have  a  roughly 
equal  chance  of  being  afflicted  with  the  diseases 
which  are  to  be  treated  in  the  group,  then  con- 
sideration should  also  be  given  to  selecting  experi- 
mental subjects  from  the  group  on  a  random  basis. 
There  is  something  in  us  which  rebels  at  this  no- 
tion, but  once  the  field  of  experiments  has  been 
properly  limited  this  alternative  cannot  be  dis- 
missed out  of  hand.  There  are  many  other  situa- 
tions in  which  membership  in  a  group  imposes 
obligations  in  return  for  sharing  in  the  benefits 
conferred  by  membership  (such  as  the  availability 
of  improved  and  adequately  tested  pharmaceu- 
ticals). The  drafting  of  young  men  into  the  armed 
services  provides  a  current  example.  Although  I  for 
one  would  prefer  a  system  which  achieved  its  ends 
through  voluntary  heroism  rather  than  obligatory 

**The  advantages  and  disadvantages  of  such  "a-respon- 
sible"  bodies  are  explored  in  a  memorandum  prepared  by 
Prof.  Guido  Caiabresi.  Yale  Law  School,  for  a  project  on 
catastrophic  diseases  on  which  the  author  is  at  work  with 
Dr.  Jay  Katz. 


sacrifice,  such  a  system  may  not  produce  enough 
volunteers  and,  in  the  case  of  children,  it  makes  no 
sense  to  speak  of  volunteerism  anyway.  One  can 
object  to  random  selection  on  pragmatic  grounds, 
however,  for  it  fails  to  distinguish  those  children 
who  are  best  suited  for  testing  (although  it  could 
be  used  in  combination  with  the  second  alternative 
just  discussed),  and  it  may  make  adverse  test 
sequelae  more  difficult  for  the  parents  to  bear 
than  would  a  more  rational  system,  especially  one 
in  which  they  exercised  the  decision-making 
power.  Nevertheless,  the  randomness  of  the  pro- 
cedure itself  is  less  bothersome  than  the  alternative 
which  many  favor  of  using  sick  children  as  test 
subjects,  since  to  the  randomness  of  being  afflicted 
with  the  disease  and  its  accompanying  suffering 
would  be  added  the  risk  of  further  suffering  from 
a  drug  whose  safety  and  efficacy  are  unknown. 

Thus  far,  these  alternatives  have  been  discussed 
entirely  in  functional  terms,  but  it  is  obvious  that 
they  would  bring  about  important  changes  in  the 
rights  and  duties  of  the  various  participants:  chil- 
dren, parents,  investigators,  and  society.  Yet  I 
suspect  that  what  makes  one  uncomfortable  about 
the  second  and  third  alternatives  is  neither  their 
deliberateness  (in  the  case  of  selection  by  fitness) 
nor  their  arbitrariness  (in  the  case  of  random  selec- 
tion), but  their  allocation  of  authority  to  officers 
of  the  state.  We  attempt  to  protect  our  liberties  by 
placing  limitations  on  the  powers  of  the  state;  yet, 
not  always  trusting  the  state  to  be  so  self-limiting, 
we  also  seek  protection  by  dispersing  power  as 
widely  as  possible  and,  when  it  is  necessary  to 
place  power  in  the  government,  by  putting  as 
many  internal  checks  on  its  exercise  as  possible 
without  disabling  the  system  entirely.  These  lib- 
erty-protecting devices  are  enshrined  in  our  con- 
stitution, as  prohibitions  on  "involuntary  servi- 
tude," guarantees  of  "due  process,"  and  the  like. 
While  the  selective  service  system  has  withstood 
challenge  on  constitutional  grounds,^  ^~^'*  any 
system  of  drafting  children  for  medical  experimen- 
tation would  certainly  be  subject  to  attack,^  *  and 
its  necessity  would  have  to  be  rather  compelling 
for  it  to  be  upheld.  One  interesting  aspect  of  this  is 
that  the  result  desired  (conducting  adequate  tests) 
might  also  be  achieved  through  the  first  alterna- 
tive, that  of  giving  parents  more  freedom  in  volun- 
teering their  children  for  research  for  the  benefit 
of  children  generally  rather  than  of  their  child  in 
particular.    And   yet    our   doubts   about  such  a 


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CLINICAL  RESEARCH 


method  would  probably  not  be  framed  in  constitu- 
tional terms  but  in  terms  of  private  rights  (the 
parents'  v.  the  child's)  in  civil  law  terms. ^* 

Limiting  Damages 

If  it  is  thus  possible  to  formulate  a  proper  class 
of  subjects  and  a  means  of  administering  the  rule 
thus  devised-and  the  alternatives  just  mentioned 
probably  do  not  exhaust  the  field-one  must  still 
face  the  prospect  that  for  all  the  narrowing  of 
need,  risks,  and  participants  there  will  still  be  cases 
in  which  the  results  wiU  not  match  the  ideal  being 
sought.  These  are  the  cases  in  which  a  child-subject 
suffers  an  injury,  which  he  will  not,  of  course, 
have  chosen.  One  way  of  reducing  the  inci- 
dence of  harm  is  to  insist  that  peer  group  review 
committees  diligently  carry  out  their  duty  of 
monitoring  ongoing  research  so  as  to  assure  that 
adequate  measures  are  always  taken  to  keep  the 
risks  within  the  limits  originally  approved  and  to 
detect  and  correct  deleterious  results  as  quickly 
and  completely  as  possible.^  ^  There  is  nevertheless 
no  assurance  that  serious  injuries  can  always  be 
prevented. 

A  partial  remedy  for  this  failing  is  to  insist  on 
full  compensation  to  the  subject,  without  regard 
to  the  level  of  diligence  and  care  exercised  by  the 
investigator.  Despite  this  description,  this  proposal 
should  not  be  confused  with  the  no-fault  systems 
of  automobile  insurance  which  are  now  being 
enacted  in  a  number  of  states.  In  those  systems, 
persons  involved  in  traffic  accidents  can  collect  a 
limited  amount  (up  to  $2,000  to  $4,000  in  most 
cases)  for  actual  expenses  occasioned  by  the  acci- 
dent (but  not  for  pain  and  suffering)  on  simple 
proof  that  the  accident  occured.  The  theory  be- 
hind this  method  of  handling  accident  compensa- 
tion is  that  it  will  reduce  the  total  costs  of  acci- 
dents and  that  the  determination  of  fault  is  often 
too  expensive,  especially  when,  in  many  situations, 
more  than  one  person  is  blameworthy  to  some 
degree.^  *'^'  This  no-fault  method  is  not  easily 
translatable  to  the  medical  sphere,  however,  be- 
cause in  many  medical  interventions,  and  particu- 
larly those  of  an  experimental  cast,  there  is  often 
no  clear  norm,  deviation  from  which  can  be  said  to 
constitute  negligence.  In  experimentation  on 
adults,  the  cost  of  the  injury  has  to  be  borne  by 
the  subject,  since  he  chose  to  expose  himself  to  it 
(and  usually  waived  his  right  to  recover).  If  there  is 
a  measure  of  injustice  in  that  instance,  there  is  en- 


tirely too  much  injustice  in  laying  this  burden  on 
the  child  who  was  selected  for  (rather  than  having 
consented  to)  the  experiment. 

Full  compensation  also  makes  good  sense  eco- 
nomically since  it  treats  injuries  like  the  other 
costs  of  developing  a  new  drug,  which  ought  to  be 
reflected  in  the  drug's  price.^**'"  If  the  costs  of 
the  injury  are  instead  borne  by  some  form  of  gen- 
eral medical  or  social  insurance,  more  drug  re- 
search will  take  place  than  is  justified  by  society's 
economic  demands.  If  insufficient  research  is 
undertaken,  because  the  market  mechanism  can- 
not adequately  collectivize  individuals'  demands 
for  medical  innovations  which  they  as  individuals 
do  not  anticipate  needing,  there  are  better  fie, 
more  precise,  fairer,  etc)  methods  for  stimulating 
the  necessary  research  than  throwing  the  cost  of 
pharmacological  mistakes  onto  experimental  sub- 
jects, for  them  to  pass  on  to  society  at  large  on  a 
haphazard  basis. 

Limiting  the  Limitations 

What  if  the  "approximation"  system  proposed 
here  does  not  work,  even  approximately?  What 
should  be  done  if  the  present  state  of  affairs-in 
which  some  children  are  injured  when  untested 
drugs  are  used  on  an  uncontrolled  basis  as  physi- 
cians and  parents  feel  they  are  needed  in  pediatric 
therapy-turns  into  another  bad  or  even  worse 
situation  in  which  there  is  widespread  injury  to 
children  in  drug  tests?  Such  a  result  is  possible;  it 
could  occur  if  the  mechanisms  for  selection  were 
set  in  such  a  way  that  they  turned  out  a  large 
number  of  subjects,  thereby  overwhelming  the 
more  important  part  of  the  system,  its  cautionary 
side.  Our  legal  institutions  are  not  set  up  to  deal 
well  with  this  kind  of  problem.  In  particular,  the 
courts,  once  they  have  faced  up  to  a  difficult, 
nagging  problem,  tend  to  frame  a  "big"  solution, 
one  which  can  perhaps  be  stated  in  terms  of  immu- 
table rights  and  duties.  Thus  wound  up,  the  solu- 
tion is  supposed  to  run  by  itself  for  quite  a  while. 
Although  this  is  not  true  of  all  judges  as  indi- 
viduals, it  fairly  describes  the  system  as  a  whole. 
This  may  seem  odd,  since  the  common  law 
method  is  supposed  to  be  a  flexible  means  of 
making  incremental  changes  in  the  law.  Yet  de- 
spite this  ability  to  tinker  on  the  margins,  or  per- 
haps because  of  it  (so  as  to  keep  the  tinkering  of 
individual  judges  within  narrowly  confined  limits), 
the  common  law  system  emphasizes  basic  prin- 


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LEGAL  CONSIDERATIONS  IN  CHILD  STUDIES 


149 


ciples,  which  are  seen  for  the  most  part  as  un- 
changing. Of  course,  there  are  always  more  than 
enough  principles  to  go  around,  so  that  for  any 
rule  or  result  there  is  counterrule  or  counterresult 
supportable  by  as  many  venerable  principles.  Yet, 
once  a  certain  principle— for  example,  that  a  child 
has  a  right  not  to  be  subject  to  nonbeneficial  med- 
ical interventions-is  established,  that  principle 
tends  to  close  out  the  field.  Through  the  doctrine 
of  deciding  according  to  precedent  (stare  decisis), 
decisions  are  held  within  a  small  compass,  and 
when  confronted  with  the  need  to  make  a  major 
adjustment  in  the  system  a  court  is  reluctant  to  act 
because  to  do  so  it  must  overthrow  the  weight  of 
precedent. 

Legislatures,  which  are  under  no  such  con- 
straint, are  usually  too  cumbersome  to  permit 
keeping  tract  of,  and  making  adjustments  in,  sys- 
tems of  the  type  we  have  been  considering.  This 
function  is  usually  delegated  to  administrative 
bodies,  whose  record  for  originality  to  say  nothing 
of  speed  is  hardly  commendable. 

I  mention  all  this  because  it  seems  to  me  that  in 
this  area,  as  in  so  many  others,  the  law  (which  is 
fundamentally  a  means  for  accomplishing  an  end 
desired  by  society)  needs  the  kind  of  flexibility 
which  can. only  come  from  periodic  monitoring  of 
the  results  being  reached  and  an  adjustment  of  the 
established  rules  so  that  they  might  better  serve 
the  intended  ends.  Yet,  while  this  limitation 
should  be  part  of  any  model  of  successive  approxi- 
mations, I  do  not  have  great  faith  in  the  legal 
system's  ability  to  provide  it. 

Conclusion 

Pediatric  clinical  pharmacology  is  confronted 
with  the  medicolegal  dilemma  that  on  the  one 
hand  drugs  which  have  not  been  tested  on  children 
either  cannot  be  used  to  treat  them  or  must  be 
used  in  a  fairly  unscientific  and  risky  fashion,  and 
on  the  other  hand  the  needed  drug  testing  may 
itself  be  foreclosed  in  the  pediatric  age  group  if  no 
one  is  authorized  to  give  informed  consent  for  a 
child's  participation  in  medical  interventions  that 
are  not  intended  to  benefit  him  directly.  Although 
the  ideal  soiution-fully  voluntary  participation  by 
well-informed  subjects  who  undertake  the  risks  of 
a  drug  trial  as  co-adventurers  with  the  clinical 
investigators— is  not  possible  in  pediatric  pharma- 
cology, a  model  of  successive  approximations  may 
reduce  the  scope  of  the  problem  to  more  manage- 


able proportions.  The  model  operates  by  first 
limiting  the  perceived  need  and  the  risks  and  then 
by  replacing  the  concept  of  substituted  informed 
consent  with  various  modes  of  choosing  the  pedi- 
atric subjects,  such  as  selection  by  guardian,  by 
professionals  on  basis  of  fitness,  or  by  lot.  Finally, 
the  model  would  attempt  to  limit  the  impact  of 
injuries  suffered  by  providing  for  full  compensa- 
tion to  the  subjects.  The  proposed  approach  is  not 
presented  as  a  panacea  for  this  very  difficult  prob- 
lem but  as  an  attempt  to  encourage  legal  and 
medical  re-examination  of  current  methods  of 
dealing  with  the  issue. 

References 

l.Shirkey  H:  Therapeutic  orphans.  J  Ped  72:119-120, 
1968. 

2. Senate  Committee  on  Government  Operations:  Inter- 
agency Drug  Coordination.  Sen  Rep  No  1153,  89th 
Cong  2nd  Sess.,  22-29,  1966. 

3.21  use  §355,1972. 

A.Seell  CFR  §130.3  erse<7,  1972. 

5. Food  and  Drug  Administration:  Proceedings  of  a 
Conference  on  Pediatric  Pharmacology.  Washington, 
US  Gov't  Ptg  Off,  1967. 

6.  Lowe  CU:  Pediatrics -proper  utilization  of  children  as 
-  research   subjects.   Ann   NY   Acad  Sci   169:337-343, 

1970. 

7.  Lockhart  JD:  The  information  gap  in  pediatric  drug 
therapy.  Mod  Med  38:56-68,  Nov  16,  1970. 

8.21  CFR  §130.4,  1972. 

9.Natanson  v  Kline,  186  (Kan.  383,  410,  350  P.2d  1093, 
1106,  clarified,  187  Kan.  186,  354  P.2d  670  (1960). 

lO.Curran  WJ,  Beecher  HK:  Experimentation  in  children. 
JAMA  210:77-81,  1969. 

11.126  F.2d  121  (DCCir  1941). 

12. 126F.2dat  123. 

13.  Petition  in  Foster  v  Harrison,  Mass  Sup  Jud  Court, 
Suffolk,  SS  No  68674  Equity,  1957. 

14.445  SW2d  145  (Ky  1969). 

IS.See  Bakker  v  Welsh,  144  Mich  632  (1906). 

16. American  Academy  of  Pediatrics,  Committee  on 
Drugs:  Drug  testing  in  children -FDA  regulations.  Ped 
43:463-465,  1969. 

n.Katz  J,  with  Capron  AM,  Glass  ES:  Experimentation 
with  Human  Beings.  New  York,  Russell  Sage  Founda- 
tion, 1972. 

18.Krugman  S,  Giles  JP,  Hammond  J:  Viral  hepatitis  type 
B  (MS-2  strain)-studies  on  active  immunization. 
JAMA  217:41-45,  1971. 

19. Editorial:  Prevention  of  viral  hepatitis-mission  im- 
possible? JAMA  217:70-71.  1971. 

20.Goldby  S:  Experiments  at  the  Willowbrook  State 
School.  Lancet  1:749,  1971. 

21. Heller  J:  Syphilis  victims  in  US  study  without  therapy 
for  40  years.  NY  Times,  Jul  26,  1972,  pp  1,8. 

22.  Selective  Draft  Uw  Cases,  245  US  366  (1918). 

23.Lichter  v  United  States.  334  US  742  (1948). 


ISO 


896 


CLINICAL  RESEARCH 


24.  United  States  v  O'Brien,  391  US  367  (1968). 

25. Cf  Black  C  Jr:  Constitutional  problems  in  compulsory 

'national  service.'  Yale  Law  Report,  Summer  1967,  pp 

19-20. 
26. But  see  Prince  v  Massachusetts,  321  US  158  (1944) 

(limiting  parents'  authority  to  make  child  a  "martyr" 

to  religion,  a  constitutionally  based  argument). 
27. See    FDA    Regulations    on    Institutional   Committee 

Review  of  Clinical   Investigations   of  New  Drugs  in 

Human    Beings.    36    Federal    Register    5037,    1971, 

amending  21  CFR  §130.3,  1972. 


28.Calabresi  G:  The  Costs  of  Accidents.  New  Haven,  Yale 

University  Press,  1970. 
29. Blum  WJ,  Kalven  H  Jr:  Public  Law  Perspectives  on  a 

Private  Law  Problem.  Boston,  Little,  Brown  and  Co, 

1965. 
30. Ladimer  I:  Clinical  research  insurance.  J  Chron  Da 

16:1229-1235,1963. 
31.Calabresi  G:  Reflections  on  medical  experimentation 

in  humans.  Daedalus  98:387^05,  1969. 


I 


897 


BURLAU  OF  PRISONS  OPERATIONS  ^lEMORANDUM  WASHINGTON,  D.G. 

7300.128 
10-25-72 

SUBJECT:  PROCEDURE  FOR  PROCESSING  PARTICIPANTS  INTO 

PROJECT  START  (SPECIAL  TREATMENT  AND  REHABILITATIVE  TRAINING) 

1.  PURPOSE; 

a.  To  provide  the  criteria  for  selection  of  inmates  for  participation  in 
Project  START. 

b.  To  transmit  procedures  for  processing  inmates  from  home  institutions  to 
Project  START. 

2.  BACKGROUND ;  In  an  attempt  to  develop  behavorial  attitudinal  changes  in 

offenders  who  have  not  adjusted  satisfactorily  to  institutional  settings, 
the  Bureau  has  recently  initiated  a  Special  Ibreatment  and  Rehabilitative 
Training  (START)  Program  at  Springfield.  The  Program  is  designed  to  pro- 
vide care,  custody,  and  correction  of  the  long  term  adult  offender  in  a 
settingjoperated  from  his  home  institution, 

3.  SELECTION  CRITERIA;  The  START  Program  will  be  for  30-35  inmates  and  those 

who  complete  the  program  will  not  be  eligible  for  return  to  STaRT.  When 
an  institution  is  screening  an  inmate  for  participation  in  the  program,  it 
is  necessary  that  the  inmate  meet  the  following  selection  criteria: 

a.  Will  have  shown  repeated  inability  to  adjust  to  regular  institu- 
tional Programs  not  just  minor  offenses. 

b.  Will  be  transferred  from  the  sending  institution's  segregation  unit, 

c.  Generally,  will  have  a  minimum  of  two  years  remaining  on  his  sen- 
tence . 

d.  Will  not  be  overtly  psychotic  (overtly  psychotic  inmates  are  appro- 
priate referrals  to  the  regular  medical  center  Psychiatric  Program, 

e.  Will  have  had  experience  in  an  adult  penitentiary, 

f .  Will  not  be  a  continuous  escape  risk,  and  in  terms  of  personality 
characteristics,  shall  be  aggressive,  manipulative,  resistive  to  authority, 
etc, 

l^,     REFFERRAL  PROCEDURES;  Institutions  wishing  to  refer  inmates  to  START  will 

request  transfer  authorization  from  the  Office  of  the  Coordinator  of  Men- 
tal Health  Services,  This  request,  submitted  by  the  Warden,  should  con- 
tain a  thorough  narrative  justification  supporting  such  a  transfer  and 
docxamenting  how  an  inmate  fulfills  selection  criteria. 

All  transfers,  in  and  out  of  this  program,  will  go  through  the  Office  of 
the  Coordinator  of  Mental  Health  Service, 

5.  THIS  OPERATIONS  JvlE^iORANDUM  IS  CANCELLED  EFFECTIVE  OCTOBER  31.  1973. 

NORMAN  A.  CARLSON 

Director,  Bureau  of   Prisons 


898 


BUREAU  OF  PRISONS  WASHiMGTON,  D.  C.  20537 

Policy     Statement 


SUBJECT: 


RESEARCH 


6110.1 


10-31-67 


1.      PURPOSE. 


To  state  that  it  is  the  policy  of  the  Bureau  of  Prisons  to 
encourage  and  promote  research  activities,  i.e.,  projects 


undertaken  by  individuals  or  organizations  either  in  or  out  of  Federal, 
state,  or  local  governments  where  the  Bureau  of  Prisons  assumes  either  a  host 

or  sponsorship  role.  .    _        :-,:.  y:..;  ' 

2.  POLICY   The  Bureau  of  Prisons  will  actively  cooperate  in  all  research 

activities  which  meet  the  following  four  conditions: 

(a)  The  "researcher",  either  as  an  individual  or  organization  has  a 
bona  fide  professional  standing  in  the  pertinent  field; 

(b)  The  benefits  are  clear  in  terms  of  the  mission  and  collateral 
objectives  of  the  Bureau  of  Prisons  and  the  potential  for  benefit 
or  advancement  of  knowledge  warrants  involvement  and/or  invest- 
ment of  funds,  facilities,  and  services; 

(c)  The  activity  does  not  adversely  affect  Bureau  of  Prisons  programs 
or' operations;    ...  .   •..::•=•.•;*••.. 

(d)  In  the  case  of  medical  projects  (where  the  direct  application  to 
corrections  is  submerged  in  the  significance  of  the  project  as 

"■•  "    a  benefit  to  mankind  and  where  the  project  would  be  difficult 

if  not  impossible  to  conduct  in  other  than  a  controlled  setting 
'  - '  "  such  as  is  offered  in  an  institution). 

It  will  be  the  policy  of  the  Bureau  of  Prisons  to  assign  priorities.   Research 
which  is  innovative  and  contributes  to  the  development  of  the  correctional 
profession  is  especially  desirable.   Projects  that  are  of  lesser  concern  to 
medicine  and  corrections,  or  which  are  primarily  for  the  individual's  benefit, 
will  be  assigned  a  lower  priority.   These  latter  projects  will,  however,  be 
considered  if  they  require  minimal  use  of  institution  resources.  . 

3.  CRITERIA   '■■  "  ■■■''■"  ••''■-" "- ;.   •.? 

a.   Correctional  Programs.   Research  in  correctional  programs  (which,  by 

implication,  may  include  many  facets  of  the 
social  sciences)  is  especially  desirable,  particularly  where  such 
research  has  promise  for  advancing  knowledge  and  capability  for  treat- 
ment of  offenders..  Emphasis,  however,  should  be  given  those  projects 
having  a  primary  corrections  component.  ... 


899 


Page  1 
6110.1 
10-31-67 

b.  Operational  Programs,   While  few  research  programs  relating  solely 

to  operations  have  been  conducted  in  the  past, 
the  rapid  gains  in  science  and  technology  make  it  likely  that  such 
projects  may  be  done  more  frequently  in  the  future.   Because  of  this 
and  because  such  projects  may  result  in  immediate  and  material  bene- 
fits, the  definition  of  research  may  be  expanded  to  include  experimenta-. 
tion  and  demonstration,  even  that  conducted  by  commercial  firms  at  no 
cost  or  obligation  and  with  the  understanding  that  government  partici- 
pation does  not  imply  any  endorsement. 

c.  Medical  and  Psychiatric  Programs.   Except  in  unusual  and  highly  justi- 

fiable circumstances,  research  in 
these  areas  will  be  conducted  by  the  U.S.  Public  Health  Service  with 
the  joint  approval  of  the  In ti^c "Bureau  Committee  on  Health  Services 
Research  and  the  Bureau  of  Prisons  within  the  policy  framework  estab- 
lished by  the  National  Advisory  Health  Council  as  follows: 

"Be  it  resolved  that  the  National  Advisory  Health  Council 
believes  that  Public  Health  Service  support  of  clinical 
research  and  investigation  involving  human  beings  should 
be  provided  only  if  the  judgment  of  the  investigator  is 
subject  to  prior  review  by  his  institutional  associates 
to  assure  an  independent  determination  of  the  protection 
of  the  rights  and  welfare  of  the  individual  er  Individuals 
involved,  of  the  appropriateness  of  the  methods  used  to 
secure  informed  consent,  and  of  the  risks  and  potential 
medical  benefits  of  the  investigation."  (See  Appendix  1 
for  consent  form  to  be  used  in  medical  projects)  ,  .. 

In  addition,  the  Bureau  of  Prisons  will  be  guided  by  the  ethical  stanr 
dards  suggested  by  the  statement  of  permissible  medical  experiments  on 
volunteers  prepared  by  the  War  Crimes  Trial  Prosecutors  at  Nuremberg. 
(Appendix  2) 

4.   GENERAL  CONDITIONS  .  :,'•  !l':"'' . '  ':  • 'T/^.'  ^^^  '  \V  V..- 

a.  Research  Assumption  of  Responsibility.  As  a  condition  of  Bureau  of 

Prisons  cooperation  and  partici- 
pation, researchers  will  assume  responsibility  for  the  protection  of  the 
rights  and  lives  of  individuals  involved  and  for  the  continued  treatment 
of  complaints  or  problems  that  may  arise  at  any  time,  even  after  project 
termination.  -  . 

b.  Informed  Consent  of  Participants.   It  is  a  firm  principle  that  no  one 

should  be  subject  to  arbritrary  risks 
against  his  will  and  informed  consent  is  required  of  all  participants  in 
research  projects.  This  requires  obtaining  a  consent  and  release  state- 
ment from  each  participant  which  statement  must  include  the  stipulation 
that  the  subject  may  freely  withdraw  from  participation  at  any  time  with- 
out penalty  of  any  kind.  (See  Appendix  1  and  4.) 


900 


Page   2. 

6110.1 

10-31-67 

c.  Inmate  Incentives.   The  opportunity  to  participate  in  a  wholesome 

activity,  such  as  research  holding  the  promise 
of  advancing  knowledge  and  capability,  is  considered  to  be  sufficient 
incentive  for  inmate  participation.   On  this  basis,  offering  inmate 
incentives  of  a  material  nature  seems  inappropriate  and  doing  so 
should  be  discouraged.   However,  in  the  light  of  past  practice,  and 
particularly  in  the  case  of  medical  research  projects  involving  some 
degree  of  personal  risk  or  discomfort,  incentives  such  as  extra  good 
time  and  monetary  awards  may  be  approved.   In  line  with  the  foregoing, 
the  nature  of  the  incentive  involved  and  the  justification  therefore 
must  be  documented  at  the  time  the  proposed  project  is  submitted  to 
the  Central  Office  for  approval. 

d.  Publication  Rights.   Unless  otherwise  mutually  agreed  to,  the  researcher 

may  publish  at  his  own  expense  the  results  of  pro- 
ject activity  without  prior  Bureau  of  Prisons  review,  provided  that  such 
publication  (written,  .visual,  or  sound)  contains  an  appropriate  acknow- 
ledgment of  Bureau  of  Prisons  participation,  and  provided  further  that 
such  participation  does  not  imply  approval  or  endorsement  of  such  pub- 
lication. Also,  unless  otherwise  mutually  agreed  to,  the  researcher 
shall  furnish  ten  (10)  copies  of  any  such  publication  to  the  Bureau  of 
Prisons  and.  In  the  case  of  original  books,  manuals,  films,  or  other 
copyrightable  material  produced  by  non- federal  government  researchers, 
such  material  may  be  copyrighted  but  the  Bureau  of  Prisons  reserves  a 
royalty-free,  non-exclusive  and  irrevocable  license  to  reproduce,  pub- 
lish, translate,  or  otherwise  use,  and  to  authorize  others  to  publish 
and  use  such  materials. 

e.  Assurance  of  Compliance  with  Civil  Rights  Act  of  1964.   It  will  be 

necessary  in 
the  case  of  non-federal  government  researchers  for  the  institution  to 
obtain  a  written  assurance  of  compliance  with  the  Civil  Rights  Act  of 
1964  and  the  appropriate  regulations  of  the  Department  of  Justice 
(28  CFR  Part  42).   The  form  of  assurance  required  is  attached  as 
Appendix  3. 

f .  Project  Controls.   The  Chief  of  Research  of  the  Bureau  of  Prisons  will 

stipulate  at  the  time  a  project  is  approved  how  many 
reports  of  progress  must  be  submitted  by  the  researcher  and  the  in- 
tervals which  they  must  be  submitted.   The  fixing  of  the  intervals 
will  be  determined  by  the  nature  of  the  project.   The  Project  Director 
is  responsible  for  submission  of  a  progress  report  to  the  Warden  every 
six  months  after  the  beginning  date  of  the  project  and  more  frequently 
to  the  Bureau  if  appropriate.   Major  changes  in  project  design  shall 
also  be  reported  when  proposed.   The  Warden  shall  transmit  a  copy  to 
the  Bureau.  All  research  personnel  are  required  to  observe  the  rules 
of  the  institution  in  which  they  work.   The  Bureau  also  retains  the 
prerogative  to  suspend  or  terminate  any  project  at  any  time  if  there 
is  reason  to  believe  that  continuation  of  the  project  will  be  detri- 
mental to  the  inmate  population  or  the  functioning  of  the  institution 
staff  and/or  program. 


901 


Page  3 
6110.1 
10-31-67 


5.   RESEARCH  PROPOSAL  FORMAT  AND  CONTENT. 


a.  General.   Each  proposed  project • shall  be  fully  described  as  indicated 

in  the  following.   The  description  should  be  in  sufficient 
detail  to  permit  full  understanding  of  what  is  to  be  done  and  how,  and 
to  permit  complete  consideration  for  undertaking.    Four  (4)  copies  of 
the  proposal  are  required  for  submission  to  the  Central  Office,  includ- 
ing any  attachments  or  exhibits  and,  in  the  case  of  projects  where 
approaches  are  made  in  the  field,  four  copies  of  the  institutional 
report  and  recommendation  are  also  required. 

b.  Project  Svunmaries.    In  recognition  of  the  fact  that  development  of 

a  complete  proposal  frequently  requires  considerable 
investment  of  time,  the  proposal  may  be  submitted  to  the  Warden  for 
submission  to  the  Central  Office  in  preliminary  form  for  preliminary 
reaction.   This  may  be  a  brief  summary  but  in  sufficient  detail  as  to 
permit  full  consideration  and  evaluation  at  the  Central  Office  by  the 
Chief  of  Research.   Approval  of  a  preliminary  project  summary,  however, 
does  not  signify  final  approval  of  the  project.   Final  approval  will 
be  considered  only  after  the  complete  proposal  has  been  completed  and 
evaluated. 

c.  Proposal  Format  and  Content,  The  proposal  should  be  organized  as 

follows :  /- 

(1)  Name.  List  full  name  and  address  of  researcher,  vita,  including 
relevant  research  experience  and  capabilities  and  list  of  publi- 
cations, if  any. 

(2)  Title  of  Project 

(3)  Name  and  title  of  person  who  will  supervise  the  project. 

(4)  Project  summary.   Include  a  brief  (200-500  words)  summary  of  what 
will  be  done,  how,  intended  purpose,  and  the  anticipated  results. 

(5)  Project  duration.   Show  proposed  beginning  and  ending  dates. 

(6)  Statement  of  the  general  problem  and  specific  purpose  of  the  pro- 
posed project.   Describe  the  nature  of  the  problem  and  the  need  to 
be  met  and  what  it  is  that  the  project  is  expected  to  achieve. 

(7)  Methodology.   Describe  what  is  to  be  done,  how,  and  by  whom. 

(8)  Resources.   Describe  the  resources  the  researcher  will  put  into 
the  project  under  the  headings  of  (i)  personnel,  (ii)  supplies 
and  materials,  (iii)  equipment,  and  (iv)  "other".   Describe 
also  the  investment  required  of  the  host  institution  and  Bureau 
of  Prisons  under  the  same  headings  and,  in  addition,  describe 
space  and  personnel  requirements  of  the  host  institution.  Also,  / 
show  project  effects,  if  any,  on  institutional  programs  and      \ 
operations. 


93-999  O  -  73  -  pt.  3—8 


902 


6110.1 
10-31-67 

(9)  Results.  Describe  anticipated  results,  paying  attention  to 
(i)  significance,  (ii)  immediate  or  potential  benefits,  and 
(iii)  innovations  or  new  knowledge  likely  to  result. 

(10)  Inmates.   List  inmate  involvement  by  number,  type,  time  and 
extent  of  required  participation.   Show  inmate  incentives  to 
be  offered,  if  any,  and  justify  where  proposed.   Indicate 
risks  involved,  if  any,  as  a  result  of  project  participation; 
state  how  participants  will  be  notified  of  such  risks;  state 
whether  written  consent  will  be  obtained,  and;  state  clearly 
how  liability  will  be  assumed  and  what  actions  or  continued 
"after-care"  will  be  available  in  the  event  risks  do  materialize. 

(11)  Project  continuation.   Indicate  whether  project  will,  in  fact, 
.  be  terminated  after  project  duration  expires  or  whether  a 

second  phase  or  continuation  of  some  type  will  be  required. 
If  yes  to  either,  indicate  whether  Bureau  of  Prisons  coopera- 
tion and  participation  will  again  be  required. 

(12)  Project  endorsement.   Indicate  by  either  attaching  letters  or 
other  appropriate  documentation  whether  proposed  project  has 
been  endorsed  by  others,  and,  in  the  case  of  medical  projects, 
attach  written  evidence  of  prior  independent  determination  as 
required  by  the  policy  of  the  National  Advisory  Health  Council 
(see  paragraph  3). 

(13)  Institution  review.   Each  institution  will  establish  a  Warden's 
Advisory  Committee  on  Research.   This  standing  committee,  which 
will  be  representative  of  the  personnel  and  departments,  will 
initially  review  all  projects  proposed  for  their  institution 

to  estimate  what  effect  the  project  would  have  on  Institutional 
programs,  what  resources  of  inmate  and  staff  would  be  required,  and 
any  other  appropriate  considerations.   The  Committee  will  report 
their  findings  to  the  Warden,  along  with  their  recommendations. 

^   '  .  . 

(14)  Summarizing  understanding.   Where  an  arrangement  is  recommended 
with  another  Government  agency  or  non- Government  organization  or 
individual  that  involves  the  use  of  resources  such  as  manpower, 
space,  facilities,  supplies  or  equipment,  a  formal  memorandum  of 
understanding,  inter-agency  agreement,  or  contract  should  be 
effected.   Therefore,  all  necessary  elements  to  be  included  in 
such  an  agreement,  or  a  draft  agreement,  should  be  submitted  for 
consideration. 

The  Warden,  after  reviewing  the  committee's  report,  will  then  forward 
the  proposal  to  the  Research  Branch  of  the  Bureau,  along  with  his  personal 
comments  and  a  statement  whether  or  not  he  favors  the  project  being  conducted 
at  his  institution. 

6.   CENTRAL  OFFICE  PROCESSING  AND  APPROVAL 

a.   Processing.   Research  proposals  made  at  the  institutional  level  shall  be 
reviewed  and  coordinated  locally  prior  to  submission  to  the 
Central  Office."  Local  review  and  coordination  shall^give  consideration 


903 


Page  5 
6110.1 
10-31-67 
to  the  requirements  of  this  policy  memorandum.   Under  the  direction 
of  the  Warden,  proposed  projects  shall  also  be  reviewed  by  the  local 
Research  Committee,  giving  consideration  to  such  local  policies  and 
conditions  as  may  be  pertinent  as  well  as  the  requirements  for  space, 
personnel  time  and  other  institution  requirements.   Submissions  to 
the  Central  Office  level  should  be  addressed  to  and  shall  be  co- 
ordinated and  reviewed  under  the  direction  of  the  Chief  of  Research. 

b.  Submission.   Four  copies  of  the  research  proposal  and  four  copies  of 

the  institutional  review  shall  be  submitted  to  the  Central 
Office.  The  institutional  submission  shall  clearly  recommend  for  or 
against  the  project,  including  the  reasons  for  such  recommendation. 

c.  Function.  The  Chief  of  Research  shall  determine  whether  proposals 

submitted     warrant  review  by  representatives  of  other 
offices  and  divisions  within  the  central  office  and  schedule  such 
meetings  as  may  be  necessary  for  this  purpose.  These  meetings 
should  be  scheduled  in  advance  with  Assistant  Directors  or  their 
designees  and  copies  of  proposals  distributed  a  minimum  of  one  week 
prior  to  the  meeting. 

d.  Approval.  All  projects  are  subject  to  the  approval  of  the  Director 

of  the  Bureau  of  Prisons  which  approval  authority  is  not 
delegated. 

e.  Notification.   The  head  of  the  institution  involved  and  principal  in- 

vestigator shall  be  notified  in  writing  of  approval  or 
disapproval  of  the  proposal  within  five  weeks  of  its  submission  to  the 
Central  Office.  <.-    ' 


MYRL  E.  ALEXANDER 
Lrector,  Bureau  of  Prisons 
Commissioner,  Federal  Prisons  Industries,  Inc. 


904 

CRVNIE  AND  DEL3S^3QUE^JCY  SSSUES: 

A  SVIonograph  Series 


ent  and 


of  Coercive  Behavior 
Modification  Techniques 

With  Offenders 


by 
Ralph  K.  Schwitzgebel,  Ed.D.,  J.D. 

Harvard  University 


National  Institute  of  Mental  Health 
Center  for  Studies  of  Crime  and  Delinquency 

5454  Wisconsin  Avenue 
Chevy  Chase,  Maryland    20015 


February  1971 


905 


IV.  Gcnclusicn 

A.  Criminal  Justice  System 

The  discussion  above  has  briefly  described  the  development  of 
behavior  modification  techniques  and  has  indicated  in  broad  out- 
line some  of  the  legislative,  administrative,  and  judicial  approach- 
es related  to  its  regulation.  Although  behavior  modification  tech- 
niques appear  to  be  remarkably  effective  in  some  individual  cases 
when  treated  within  a  clinic  or  laboratory,  there ~lias~l3een  no'^ 
broad  scale  application  of  these  techniques  to  offenders.  If  such  a 
broad  scale  application  does_occur,  it  will  have  to  take" place  within" 
the  general  context  of  the  criminal  justice  system.~Cfiticisms  of' 
this  system  are  not  diTfiJcult~folihcr 

It  has  been  suggested  by  Teeters  that  "It  is  not  just  the  phi- 
losophy of  imprisonment  that  is  'sick'  but  rather,  the  entire  classi- 
cal theory  of  criminal  law.  We  are  operating,  by  and  large,  under 
eighteenth  century  concepts,  all  of  which,  from  police  to  court 
trial  and  sentencing,  are  pathetically  outmoded  and  clamor  for 
outright  change.*'  **'^  Similarly,  Barnes  in  an  article  entitled  "Sci- 
entific Treatment"  comments,  "  [ W]  e  cannot  achieve  anything  like 
complete  success  until  the  old  punitive  philosophy  and  the  conven- 
tional prisons  are  abolished,  root  and  branch.  It  is  as  futile  to  try 
to  graft  a  rational  treatment  of  criminals  on  the  traditional  prison 
system  as  it  would  be  to  attach  a  motor  car  to  an  ancient  stage- 
coach." ^»2 

But  criminologists  are  not  alone  in  their  criticism  of  the  crim- 
inal justice  system.  Thus,  Karl  Menninger  inveighs,  "The  con- 
cept [of  justice]  is  so  vague,  so  distorted  in  its  application,  and 
usually  so  irrelevant  that  it  offers  no  help  in  the  solution  of  the 
crime  problem  which  it  exists  to  combat  but  results^  in  the  exact 
opposite — injustice,  injustice  to  everybody."  ^''^  This  criticism  is 
not  entirely  inappropriate^sji  inflection  of  one  of  the  most  "fero- 
cious^'j)enaj_pdk2esj)^jji)^  we  presently  have 

approximately  1.3  million  persons  sub  j^ect  tocorrectioiial^  author-"" 
i^^ll.serjillng_somej)f_y^^  sentences  in  the  world.*®® 

More  specifically,  the  present  study  shows  tentatively  tHat  the 
criteria  in  the  statutes  that  are  used  to  define  sex  offenders,  habit- 
ual offenders,  and  drug  addicts  are  often  vague  and  clearly  incon- 

62 


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sistent  among  the  States.^^"  Further,  the  criteria  used  for  the  re- 
lease of  offenders  from  confinement  under  these  statutes  are  not 
closely  related  to  the  criteria  used  to  incarcerate  them.^*^  Finally, 
administrativ?  stcndards  aro  puOily  defined  and  court  intervention 
has  become  necessary  to  safeguard  some  of  the  fundamental 
rights  of  offenders. 

Situations  such  as  this  are  fertile  ground  for  the  development 
of  proposals  for  reform.  (Getting  these  proposals  translated  into 
actual  programs  is  another,  more  unlikely,  event.)  For  example, 
it  is  clear  that  prison  administrators  have  very  great  discretion 
and  that  there  is  much  potential  for  abuse.  Silverberg  suggests 
that,  "[I]n  this  country,  where  trained  and  reliable  staff  is  scarce, 
environment  control  might  best  be  accomplished  by  automating 
much  of  prison  life,  since  it  is  easier  to  see  to  it  that  a  machine 
does  not  abuse  prisoners  than  to  insure  that  a  thoughtless  guard 
will  not."  ^'^^  Perhaps  more  promising,  and  likely  of  adoption,  are 
proposals  for  the  treatment  of  offenders  based  upon  concepts 
derived  from  learning  theory.  As  well  pointed  out  by  Schwartz  in 
"A  Learning  Theory  of  Law,"  ^*°  derivatives  of  learning  theory 
may  be  usefully  applied  to  the  understanding  of  the  effects  of 
criminal  sanctions  and  the  classification  of  deviant  behavior. 

B.  Behavior  Modification  Techniques 

Some  of  the  difficulties  in  the  criminal  justice  system,  such 
as  the  inconsistent  definition  of  offenders,  cannot  be  corrected 
merely  by  an  increased  use  of  behavior  modification  techniques. 
On  the  other  hand,  behavior  modification  techniques  are  remark- 
ably well  suited  for  integration  into  the  criminal  justice  system 
because  they,  and  their  underlying  theories,  focus  upon  behavior, 
and  mbsf'off ehses~involve  obseirvable  behavior.'ITrilikertreatment 
'orientatIonsl;]iaf  focus  "upon  goals  slTch'aslrrental  health,  which  are 
diffuse  and  difficult  to  define,  behavior  modification  goals  are 
readily  measurable.  Thus,  questions  about  the^  ^^^^ly^!}*!5Li^^_i'^^ 
^PRI?^^^^4^its_influence  onjth^  criminal  justice  system  can  be 
answered  by  empirical  study  rather  than  by  speculation  unsu'p^ 
ported  by  data.^®^ 

-The_promise  of_Jbehavior_modification  techniques  lies  not  so 
much  in  accomplishments  to  date  as  in  the  success  of  clinical 
and  laboratory  experiments  and  in  the  general  methodology.  In 


••'  An  example  of  theoretical  speculation  beyond  data,  perhaps  even  beyond  reason,  usin^ 
mental  health  concepts  is  provided  in  an  article  by  McGavran  in  which  the  physician,  with 
other  members  of  the  public  health  team,  may  become  "the  doctor  of  the  body  politic."  In 
this  article  the  entire  community  is  viewed  as  a  patient  to  be  healed  by  the  physician.  Presum- 
ably this  includes  the  police  and  courts  as  well  as  correctional  authorities.  McGavran.  E.  G., 
Scientifle  Diagnosis  and  Treatment  of  the  Community  as  •  Patient.  Jonrnnl  of  the  Atneriean 
Medical  Attoeiation.  162:  723-727,  1066. 

63 


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thp^tirca  o_f_ope_rant  con^jtl^^  such  as  food,  release 

from  an  instihution,  or  money  have  been  successful  to  mod- 

ify delinquent:  behavior.  Further  study  needs  to  be  done  on  the  dur- 
ation of  these  changes  in  community  settings.  Jn  the_ar_ea_o.l classi- 
cal conditioning,  aversive  stimuli  such  as  emetics  or  electric  shock 
have  been  used  with  alcoholics  and  homosexuals!  The^aveVsive" 
stimulus  in  this  procedure  precedes  by  a  verybrief  interval  the 
behavior  to  be  modified.  This  results  in  a  reduced  frequency  of  the 
behavior  subsequently.  In  another  technique,  aversive  suppression, 
the  aversive  stimulus  follows  the  behavior  to  be  modified.  This  is 
similar  to  the  traditional  procedures  of  punishment. 

Classical    conditioning    with    aversive    stimuli    and    aversive 
suppression  are  unpleasant  for  the  offender  and  legal jcoerciori  may 
be  required  to  obtain  participation  in  the  treatment  procedures. 
Also,  some  ethical  issues  may  be  raised  in  regard~tbl:he~extent'"to* 
which  the  community  may  employ  aversive  procedures  against  ah 
offender's  will  to  prevent  predicted,  subsequent  offehses7In  classi-^ 
cai  conditioning,  however,  there  is  a  newly  emerging  trend  that 
emphasizes  the  pairing  of  pleasant  stimuli  with  behavior  that  com-* 
petes  wifh  the  illegaTb'ehavioi\  For  example,  heterosexual  behavior 
is  increased  by  conditioning  in  order  to  reduce  homosexual  be- 
iravnor.~Therpositive  results  of^thfs  research  are  "encouraging"  but 
lnore~long-tefm~followup  studies  are  required: — 

Ejecti-bnic^monitoring  ah^  have  been  de- 
signed and  used  with  offenders  in  prototype  Torm7*IJarge"'scale 
systerns  have  hot  yeT'beefi~used.""Cbm'plex^  are  in  lab- 
Qi'f^-"^.9AT..^?vGJ^P^6"^  ^^^^  can  provide  two-way  communication 
with  qflfenders  in  the  community  as  well  as  the' c'ohtihuar  monitor-' 
ing  of  their  geographical  locarrdh.  lt~would~appeai~that~mtteh'' 
crmie  can  be  technologically  prevented;  however,  procedures  heed . 
to  be  developed  for  the  effective  regulation  of  the  use  of  this  equip- 
ment  to  avofd'undue'cb'ercion  by  the  goverhmentT  

Therapeutically,  electronic  systems  can  allow  the  offender  to  re- 
main in  the  community  where  he  must  ultimately  learn  to  live. 
Also,  behavior  modification  techniques  such  as  operant  and  classi- 
cal conditioning  procedures  can  be  remotely  applied.  The  long- 
term  therapeutic  potential  of  these  systems,  independent  of  their 
immediate  crime  prevention  capabilities,  is  the  subject  of  present 
research. 

Behavior  modification  techniques  are  not  tied  exclusively  to  psy-. . 
chological  theory.  They  can  be  theoretically  integrated  with  socio- 
logical concepts  of  crime  causation  and  prevention.  Shah  ^®*  has  de- 
veloped one  of  these  theoretical  integrations.  He  notes : 

It  could  be  demonstrated  that  a  great  deal  of  the  be- 
havior of  organisms  exists  because  of  its  effects  on  the 

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envh'onment.  Most  human  behavior  is  social  because  it 
has  certain  effects  on  other  people,  which  in  turn  helps 
to  establish  certain  schedules  of  reinforcement.  The  same 
reinforcement  paradigm  may  be  extended  to  larger 
groups  of  people  such  as  social  agencies  and  institutions, 
less  well-defined  groups  of  people  invob^ed  in  srcial  jraz- 
tices,  codes  of  conduct,  etc.,  and  also  smaller  groups  or 
the  neighborhood  "gang"  of  children.  These  social  prac- 
tices ultimately  refer  to  the  various  sets  of  reinforce- 
ments and  punishments  which  the  people  who  constitute 
the  agency,  institution,  or  group,  apply  to  the  behaviors 
of  other  people.  The  powerful  controlling  and  regulat- 
ing influence  of  social  norms  are  mediated  in  large  meas- 
ure by  the  reinforcing  effects  of  group  approval  and  dis- 
approval. 

Although  the  legal  and  ethical  aspects  of  research  in  behavior 
modification  have  not  been  discussed  herein,  this  is  an  area  that 
needs  further  study.  It  is  likely  that  the  courts  will  allow  some- 
what more  leeway  in  the  development  of  new  techniques  under 
careful  supervision  and  appropriate  procedural  safeguards  than 
in  the  application  of  techniques  already  developed  to  large  popula- 
tions with  general  supervision.**'^ 

C.  Legal  Regulation 

The  development  of  appropriate  standards  for  the  application 
of  behavior  modification  techniques  requires  some  flexibility  and 
tentativeness.  Although  judicial  and  legislative  opinion  is  now 
helpful  in  setting  the  outer  limits  of  permissible  treatment,  re- 
strictive case  law  and  statutes  based  upon  inadequate  information 
are  likely  to  prevent  an  advantageous  development  of  new  knowl- 
edge and  more  effective  techniques.  There  needs  to  be  an  oppor- 
tunity for  conceptual  changes  in  the  treatment  of  offenders,  at 
least  until  a  higher  degree  of  therapeutic  success  is  achieved. 
Thomas  Szasz  has  often  quoted  Seymour  Krim  to  the  efl'ect  that 
the  vocabulary  and  definitions  of  psychiatry  have  become  a  "noose 
around  the  neck  of  the  brain."  ^^*  Similarly,  the  vocabulary  and 
definitions  of  law  should  not  unduly  restrict  the  logical  develop- 
ment of  the  field  of  behavior  modification  as  they  would  if  they 
werejthe  pr edommantTenns  "detem  th! 

Rather  than  relying  upon  case"Taw"oF~statutes,  more  flexibility 
and  conceptual  integrity  could  be  obtained  by  having  professional 
organizations  and  practitioners  establish  internal  standards  and 
guidelines.  Courts  and  legislatures  could  then  look  to  these  stand- 
ards in  resolving  difficult  problems.  The  development  of  these 

65 


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standards  will,  of  course,  require  openly  confronting  some  very 
difficult  policy  issues.  For  example,  the  present  practice  of  xhe  civil 
commitment  of  offenders  for  "treatment"  often  results  in  the'long- 
term  preventive  detention  "of  some  ^property"  offendeFs'oirpefs'dns 
of^J^lpdetermi  ned_d_a^ 

could  not  be  directly  mandated  by  legislatures.  As  behavior  thera- 
pists move  out  of  the  laboratory  and  private  clinic  into  the  crimi- 
nal  justice  system,  they  will  certainly  be  involved  in  this  issue  be- 
cause  "crimirTar^behaviors^will ~  have  To  T)e~ assigned" expected 
frequencies  prior  to  treatrhent.'  '""^ 

The  application  of  behavior  modification  techniques  to  the  be- 
havior of  offenders  necessarily  involves  some  view  of  the  relation- 
ship of  the  State's  coercive  power  to  the  individual.  Silverberg 
has  suggested  that  because  foreseeable  future  prisons  are  likely  to 
be  closed  societies,  "  [W]  e_should  begin  to  think  about  operating' 
them  so  as  to  derive  maximum  benefit  from  their  l;o tali tarian  na- 
ture, ratlier  than  sweeping  this  charaHeristic  uhUer'theTrugr*"^®* 
Further,"  "The  comniunity^eed  not  protect  a~man*3  right  to~"be  a 
crjniinajjbyj^f using  to  c^^ 
it,_his  criminal  behavior)  withouthis  consent."  ^^^ 

In  contrast,  one  might  take  more  nearly  the  view  of  the  "com- 
munity" as  de  Toqueville  saw  it.  In  this  view,  the  legal  order  in  a 
democracy  is  based  upon  reciprocal  relationships  which  include 
both  complimentary  and  conflicting  viewpoints.  A  democratic  or- 
der, or  "ordered  liberty,"  does  not  rely  primarily  upon  political 
or  therapeutic  power.  Of  course,  coercive  power  must  sometimes  be 
used  when  the  behavior  of  offenders  restricts  unduly  the  freedom 
of  others,  for  example,  attacks  on  persons  using  public  streets. 
The  harm  is  not  only  measured  by  the  actual  frequency  of  attacks 
but  also  their  assumed  recurrence  that  would  make  people  fearful 
of  leaving  their  homes,  thus  restricting  their  freedom  of  move- 
ment. On  the  other  hand,  some  private,  consensual  acts  between 
persons,  now  considered  crimes,  would  be  permitted.  The  physi- 
cal restraint  of  offenders,  who  are  also  citizens,  would  be  limited 
to  that  which  was  necessary  to  maximize  the  freedom  of  action  and 
thought  in  the  community.  In  this  view,  the  long  and  ineffective 
sentences  of  imprisonment  now  often  used  would  need  to  be 
changed.  Such  changes,  however,  are  more  nearly  matters  of  pub- 
lic policy  than  therapeutic  technique. 

Whether  legal  institutions  can  regulate  the  coercive  potential 
of  behavior  modification  techniques  toward  the  implicit  jurispru- 
dential values  of  "fairness"  and  "justice"  is  an  open  question.  The 
necessary  constitutional  provisions  appear  to  be  available  but  too 
infrequently  applied  to  specific  cases  to  be  clear  in  outline.  This 
appears  to  be  not  so  much  the  result  of  judicial  reluctance  as  the 

66 


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absence  of  firm  information  about  the  effects  of  behavior  modi- 
fication techniques  on  sizeable  populations  of  offenders.  When  such 
information  becomes  rehable,  it  may  help  to  shape  judicial  opin- 
ion so  that  the  legal  limits  and  leeway  of  application  become  more 
clear. 

Very  much  more  needs  to  be  learned  about  the  potential  effects 
of  behavior  modification  techniques.  Although  considerable  gains 
have  been  made  over  the  past  15  years  of  rfipparch,  one  is  reminded 
of  Phaedrus'  mountain: 

A  mountain  was  in  labour,  sending  forth  dreadful 
gi'oans,  and  there  was  in  the  region  the  highest  expec- 
tation. After  all,  it  brought  forth  a  mouse.''^^ 

But  perhaps,  we  will  not  be  too  criticized  if,  with  occasional 
glimpses  of  success,  we  continue  to  hope  for  genuinely  effective 
and  humane  procedures  for  changing  those  behaviors  that  have 
so  long  troubled  men  and  caused  them  to  be  troubled. 


67 


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The  Medical  Department  at 
Missouri  State  Penitentiary 

By  LEO  M.  BAKER,  D.O. 

Meilical  Director  and  Admmittrator 
Mittouri  Stat*  Penitentiary 


Dr.  Baker 


at  the  Missouri  State  Penitentiary  was  built  in  1937,  and 
consists  of  a  five-story  building  with  a  basement  and  sub- 
basement.  It  is  classified  as  a  90-bed  unit;  however, 
200  beds  could  be  accommodated. 

The  entire  sub-basement  is  occupied  by  the  hospital 
laundry,  which  is  geared  to  work  twenty-four  hours  a 
day  if  the  need  arises. 

The  Morgue,  a  Medical  Records  Storeroom,  other 
storage  areas,  and  the  Dental  Department — which  has 
three  dental  chairs,  an  X-ray  unit  and  Dental  Labora- 
tory for  the  making  of  prostheses — arc  all  located  in  the 
main  basement. 

On  the  first  floor  is  the  combined  Office  of  the  Chief 
Medical  Officer-Administrator,  his  secretary,  and  inmate 
clerk.  Also  on  this  floor  are  the  Emergency  Treatment 
Room,  Medical  Records  Office,  Eye,  Ear,  Nose  and 
Throat  Clinic,  Clinical  Laboratory,  Blood  Record  Office, 
X-ray  Department,  Ojierating  Rooms  for  both  major 
and  minor  surgery,   Preparation   Room   for  all   surger) 


I.N  A  PRISON  COMPLEX  that  houses  more  than 
2,H60  inmates  many  and  varied  medical  and  psycho- 
I«>gi(al  problems  arise.  Some  are  chronic  conditions 
ill. It  the  iiuniUr  has  upon  arrival,  whihr  others  are  a<  utcr 
1  .ISIS  tiii-iliiig  iiiiiiicdiate  allciilioii.  Siu  li  probl<-ins  are 
dr. lit  wiili  by  the  ( lliirf  Mi-(li<  ill  (  Xlic cr  and  Ills  stall  and 
tliniiigli  ilu-  line  r(K»|K'rati<)n  of  the  (>onsultinn  Stall'  in 
the  specialized  fields  of  the  medical  profession.  We  feel 
tliat  the  Medical  Department  of  the  Missouri  State 
Penitentiary  meets  all  the  needs  of  the  inmates  in  a 
manner  that  surpasses  what  the  average  man  in  the 
street  could  afford  or  find  available. 

The  physical  plant  of  the  Medical  Department  here 


ABOUT  THE  AUTHOR 

Leo  M.  Baker  served  in  the  U.  S.  Navy  Hospital  Corps 
during  World  War  II,  and  after  the  war  took  his  pre-medical 
studies  at  both  the  University  of  Louisville  and  St.  Louis 
University.  He  received  his  doctorate  in  Osteopathy  from 
the  Chicago  College  of  Osteopathy  in  1951.  From  1951 
thru  1952  he  Interned  at  Lamb  Hospital  in  Denver,  Colorado, 
He  was  in  the  general  practice  of  medicine  in  Colorado  from 
1952  to  1961.  In  1961  he  began  his  residency  in  anesthesiol 
ogy  In  Jefferson  City,  Missouri,  and  completed  it  in  1963. 
He  did  post-graduate  work  In  bronchoesophagology  at  Temple 
University,  Philadelphia,  Pennsylvania;  and  after  completing 
his  post-graduate  work  he  re-entered  private  practice  as  an 
anesthesiologist  from  (963  to  1966.  During  July  1966,  he 
served  on  a  Medical  Mission,  sponsored  by  AMDOC,  to 
Shanta  Bhwana  Hospital,  Katmandu,  Nepal.  In  August  of 
1966  Dr.  Baker  was  appointed  Medical  Director  and  Ad- 
minlslralor    of   the    Missouri    State    Penitenliarv. 

He  it  a  mnmbnr  of  the  Mittouri  Otteopatnic  Attoclation, 
<he  American  Osteopathic  Association,  American  College  of 
Osteopathic  Anesthesiologists,  and  the  American  Academy 
of  Medical  Administrators. 


f 

9 


tiniiiii 
iiiinr 


IlkA. 


1 


1 

J 


Dr.  Richard  Skain,  assisted  by  an  Inmate  technician,   working  on  • 
patient   In   our   modernly   equipped    Dental    Department. 


patients.  Pharmacy,  Physiotherapy  Department,  and  an 
office  for  the  Custody  StafT. 

The  second  floor,  which  is  primarily  for  surgical  and 
medical  patients,  contains  approximately  55  beds.  There 
are  three  10-bed  wards,  one  5-bed  ward,  thirteen  private 
rooms,  a  class  room,  T.V.  room,  and  a  closed  ward  that 
has  been  set  aside  for  only  postoperative  surgical  pa- 
tients and  wheicin  the  inov«'uient  of  pnsoiuu'l  is  rc- 
stritletl  to  prevent  inlection. 

The  tiiird  floor  contains  mostly  elderly  geriatric  pa- 
tients and  those  physically  unable  to  properly  function 
in  the  inmate  population,  such  as  going  from  the  cell 

The  January-February  1968  American  Journal  of  Correction 


912 


luMisi*  to  tlir  in;iin  (liiiini;  room.  Others  housed  on  this 
lliMir  .lie  «'SMiiti;ilIy  ine<li<al  |)ers(>iiiiel  lh;U  may  he 
„(C(1((I  .It  iiii;hl :  \-i.iy.  hlood.  l,ahoriitory,  and  Siirnical 
l,(hiii<  i.itiN.  I  In-  liospiial  (het  kitchen,  under  ihrect 
^ii|)iM\  ision  <>l  a  Reuisicred  Nurse  with  an  inmate  rook, 
J5  also  convciiienlly  Uuated  here  where  special  diets  are 
nrrp.Ticd  and  served  to  all  floors. 

All  tnheroilar  and  hepatitis  patients  arc  kept  on  the 
fourth  lloor  which  is  divided  into  two  separate  wards. 
E.irli  of  these  wards  has  an  open  sun  |X)rrh. 

The  Psychiatric  I'nit  and  the  Office  of  tlir  Psyrhol- 
ojist  are  Kvatcd  on  tiie  fifth  floor.  'I'his  floor  has  no 
open  wauls  hut  is  c<Mnprised  of  twelve  private  rooms 
and  facilities  for  extirmcly  disturbed  |>atirnts. 

The  meilical  needs  of  the  inmates  are  servetl  by  a 
Chief  Medical   Officer,    his   staff,   and   combined    with 


^^-^^'^r^^r 


tion  are  placed  on  the  approprian-  floor  and  examined 
by  the  C.M.O.  If  consultation  of  an  immrdiatr  need  is 
deemed  necessary,  such  as  general  surgery  or  an  acute 
medical  case,  the  consullinn  Surgeon  or  Internist  is  con- 
tacted and  the  inmate  is  cared  for  |>rf)mptly.  'io  demon- 
strate that  this  service  is  efficient  and  effective:  recently 
an  inmate  was  hospitalized  with  a  mass  in  his  rectum. 
He  had  a  physical  examination  and  a  biopsy  was  per- 
formed that  d.ay  by  the  C.M.O.  The  specimen  was 
sent  to  the  Staff  Pathologist,  who  co'nfirmed  the  diag- 
nosis of  carcinoma  of  the  rectum.  'Ihe  Surgeon  was 
notified  and  two  days  later  the  inmate  underwent  suc- 
cessful surgery. 

K.acii  inmate  admitted  to  the  penitentiary  receives  a 
complete  physical,  dental  check-up.  eye  examination, 
blood  test,  and  immuni/ation  by  the  Medical  Depart- 
ment. As  each  man  is  examined  it  is  determined  if  the 
inmate  has  any  marked  mental  or  physical  defect.  Every 
man  is  questioned  by  the  C.M.O.  as  to  previous  surgery 
and  medical  problems  or  if  he  is  on  any  essential  medi- 
cation. He  is  closely  interrogated  as  to  presence  of 
diabetes  or  epilepsy,  and,  if  he  has  either,  the  appropriate 
medication  is  prescribed  for  him.   He  is  carefully  checked 


..^ 


Dr.  Stuart  Eion,  our  consultant  in  general  surgery,  being  assisted 
by  three  inmate  surgical  technicians  during  a  major  operation.  Dr. 
Iiler  ii  administering  the  anesthesia. 

weekly  and  semi-weekly  clinics  in  E.E.N.T.,  Optometry, 
Orthopedic  Surgery,  General  Surgery,  Internal  Medi- 
cine, Dermatology,  Psychiatry,  and  Pathology.  The 
specialists  w  ho  hold  these  clinics  are  also  willing  to  come 
at  any  time  for  emergencies  in  their  various  fields  of 
medicine.  All  anesthesia  is  administered  by  either  the 
C.M.O.  or  part  time  physician  (in  the  maximum 
STfiirity  imit)  both  of  whom  are  qualified  anesthcsiol- 
oi;ists.  Special  cases  that  need  care  in  the  fields  of 
Plastic  Surgery,  involved  Uroiogical  procedures.  Cobalt 
or  deep  X-ray  therapy  for  carcinoma  are  handled  at  the 
Medical  Center  of  the  University  of  Missouri  or  Ellis 
Fischel  Hospital  in  Columbia,  Missouri.  The  civilian 
personnel  employed  in  the  Medical  Department  and 
under  the  direction  of  the  Chief  Medical  Officer  are: 
a  Dentist,  Pharmacist,  Clinical  Psychologist,  two  female 
Registered  Nurses,  six  male  Nursing  Assistants,  and  a 
Physician  who  covers  the  maximum  security  unit  daily. 
These  very  essential  personnel  coordinate  their  depart- 
ments with  the  Chief  Medical  Officer.  Under  their 
direct  supervision  are:  inmates  who  perform  the  duties 
if  inmate  nurses;  X-ray  technicians;  blood  technicians; 
'iirpcal  technicians;  anesthesia  technicians;  emergency- 
room  technicians;  dental  technicians;  inhalation 
therapists;  physiotherapy  technicians  and  record  clerks. 
The  inmates  assigned  to  these  jobs  are  carefully  selected 
ind  thoroughly  screened. 

Daily  sick-iall,  which  averages  about  thirty-five  men, 
K  held  five  days  a  week  and  on  an  emergency  basis 
wck-cnds  and  holidays.    Inmates  in  need  of  hospitaliza- 

Thf,  Janimrv-February  1968  American  Journal  of  Correction 


r  o  n    ;•      w 


t   - 


^ 


/ 


yy^ 


.^^  a  a.:        '>.k 


fl 


Dr.  Baker,  with  the  help  of  two  of  our  surgical  technicians,  dem- 
onstrates the  use  of  the  Bennett  Positive  Pressure  Machine. 


for  any  venereal,  infectious,  or  communicable  disease. 
If  he  has  had  previous  surgery,  medical,  or  psychiatric 
care  the  name  of  the  physician  and  hospital  are  obtained 
and  a  copy  of  the  records  is  requested. 

To  assure  the  inmates  and  civilian  personnel  prompt 
care  in  cases  of  accident  or  .serious  illness  an  inmate 
"Shock  Team"  has  been  organized,  consisting  of  the 
surgical  technicians  backed  by  the  technicians  from 
X-ray,  Blood  Rank,  and  Clinical  Laboratory.  The 
technicians  from  surgery  are  well  acquainted  with  treat- 
ment of  .shock.  They  have  been  taught  to  insert  a  tube 
into  a  patient's  trachea  (wind  pi|>c)  to  insure  a  good 
airway.and  arc  well  trained  in  the  closed-chest  resuscita- 
,  tion. 


913 


f 


Twc  nHTtit  inri<l«'nts  makr  us  feci  that  it  is  a  wril 
jiiprlioniiiii  scrxicr,  e.g.,  onv  of  the  miard  forrr  stifTrrrcl 
J  srxi'if  Ih'.uI  ;m;uk  ;uul  tlic  C.MX^.  was  rallod  iin- 
fli(>(iMl<"^-  '^'  ''"'  time  lie  arrivrd,  the  "Shock  Tram" 
^,is  tluMc  and  th«"  puaid  was  rcr«*ivinp  oxyprn,  a  needle 
„.i«  in  l»is  vein  lo  ijive  liiin  the  necessary  stimulants. 
When  stnhili/e<l,  he  was  sent  to  his  family  physician,  who 
rrrditcd  our  elVorts  as  being  essential  enough  to  save  the 
man's  lif«'-  'he  other  case  was  an  inmate  who  received 
ail  abdominal  woimd  which  lacerated  the  intestines  and 
nnf  of  the  major  intestinal  vessels.  The  Surgeon  and 
C.M.O.  were  immediately  called.  When  the  C.M.O. 
arrived  at  3:15  P.M.  on  a  Sunday  afternoon,  the  pa- 
lirtit  was  on  the  operating  table.  An  intravenous 
rathrter  had  been  placed  in  a  vein  in  each  arm;  plasma 
had  heen  started :  blood  typing  ordered ;  and  donors  were 
lirinc;  matched.  The  inmate  was  examined  by  the 
Siirireon  and  C.M.O.,  anesthesia  administered,  and  by 
4:00  P.M.  the  alxlomen  was  opened  and  blood  trans- 
fiiMon  started.  His  recovery  was  uneventful  and  the 
post-operative  period  was  certainly  shortened  by  such 
prompt  care. 

Like  a  similar  number  of  men  on  the  outside,  within 
mir  inmate  [wpulation  are  heavy  smokers  and  they  have 
a  roin|\TrabIe  amount  of  chest  problems  such  as  carcin- 
oma of  hmg.  emphysema,  acute  and  chronic  bronchitis, 
and  bronchiectasis.  These  individuals  have  the  op- 
iKirtunity  of  being  offered  such  services  as  blood  counts, 
^piitiitn  exams,  and  bronchoscopies  as  deemed  necessary. 
Bronchoscopies  and  bronchograms  are  performed  by  the 
Chief  Medical  Oflficer.  Since  August  1966,  103  bronchos- 
ropirs  ha\  e  been  done  and  7  carcinomas  of  the  lung  have 
Ixrn  fi)uiul,  as  well  as  4  cases  of  bronchiectasis,  2  cysts 
nf  the  lungs,  I  i  ;ise  of  carcinoma  of  the  larynx,  and 
niirniTous  cases  nf  emphysema  and  bronchitis.  In  con- 
junction with  such  diagnostic  procedures  is  a  separate 
Inhalation  Department  and  the  inmate  technician  has 
at  his  disposal  a  new  Hennett  Intermittent  Positive  ma- 
Hiinc  which  is  used  frequently  and  cfTectivcly  on  intnates 
with  chronic-obstructive  lung  diseases,  asthmatics,  post- 
n|)crative  atelectasis,  as  well  as  patients  who  receive  up- 
per abdominal  surgery  to  prevent  post-operative  chest 
complications. 

With  the  cooperation  of  the  Missouri  Division  of 
Health  we  have  recently  completed  tuberculosis  skin 
testing  of  more  than  2,840  inmates  in  the  main  prison 
and  auxiliary  institutions.  There  were  532  men  who  had 
positive  reactions;  they  were  brought  in  and  chest  X-rays 
were  taken.  If  there  was  suspicion  of  tuberculosis,  sputum 
tests  and  further  work-ups  were  performed.  By  this  pro- 
eram  we  were  able  to  detect  other  lung  conditions  and 
institute  treatment. 

We  ha\e  a  functioning  Physiotherapy  Department 
which  is  equipped  to  apply  moist  or  dry  heat  and  cervical 
trartion.  The  technican,  who  has  been  instructed  in  the 
application  exercises,  is  able  to  help  inmates  recuperat- 
ing from  joint  injury,  surgery,  low-back  problems,  and 
arthritic  cases. 

To  maintain  nursing  personnel  among  the  inmates 
we  have  a  Nursing  Aide  Class  which  is  ably  handled  by 
our  Registered  Nurses.  This  is  supplemented  with  teach- 
ing aids  such  as  charts,  a  good  selection  of  films  on  pa- 
tient care,  and  lectures  by  the  C.M.O.  on  such  subjects 
«  acute  surgical  post-operative  care,  the  male  genital 
'\'5tem.  and  cardiac  resuscitation.  To  date  we  have 
trained  26  inmates  in  this  field. 

To  project  an  idea  of  the  extent  of  work  performed 
•w  each  of  our  various  departments  we  ofTer  this  statist- 
ical resum6  covering  a  six-month  period: 

The  January-February  1%8  American  Journal  of  Correction 


Admission  Physicals  8.50 

Daily  Sick-C;all  4,165 

Surgery  (major  operations)   149 

Surgery  (minor  operations)   222 

Surgery  (miscellaneous  procedures)   1,905 

Surgery  (application  of  casts)  60 

X-rays  Taken  1,917 

E.E.N.  T.  Treatments 1,646 

Clinical  Laboratory  Procedures  19,334 

Dental  Treatments 1,789 

Dental  Prostheses  .• 398 

Physiotherapy  Treatments 875 

Although  the  problem  of  the  control  of  drugs  and,  for 
that  matter,  all  medications,  exists  in  hospitals  on  the 
outside,  it  is  much  more  complex  within  a  prison.  This 
is  due  primarily  to  the  large  percentage  of  inmates  with 
histories  of  addiction  to  both  stimulating  drugs  and 
narcotics.  We  have  a  Registered  Pharmacist  who.se  main 
responsibility  is  the  control  and  dispensing  of  all  drugs 
and  medications.  He  also  keeps  a  perpetual  inventory 
and  sees  that  there  is  always  an  adequate  supply  of 
medications  on  hand. 


m  •«  ■«wmr^«paiamn<9r' 


rr 


I 


k.V'> 


Ti;:;^ 


'      i\ 


Mrt.  Marilyn  BuHt,  R.N.,  intUucfing  inmaf*  nurt«t  in  one  of  our 
Nursing  Aide  cUtset. 

One  of  our  very  essential  departments  is  on  the 
psychiatric  floor,  which  encompasses  the  office  of  the 
Clinical  Psychologist.  He  coordinates  the  program  to 
.see  that  the  inmates  get  proper  psychological  and  psychi- 
atric evaluation.  This  department  is  important  because 
we  are  dealing  with  people  who  are  in  a  situation  that 
produces  a  large  degree  of  anxiety.  The  pressure  and 
stress  of  their  environment  produce  a  multitude  of  mental 
problems,  from  mild  anxiety  to  acute  psychotic  episodes. 

We  feel  that  by  utilizing  the  inmates  in  our  various 
departments  we  are  helping,  to  some  extent,  in  rehabili- 
tating them  so  they  may  have  some  means  of  support 
when  they  are  released  as  well  as  having  the  opportunity 
of  being  useful  while  they  are  here.  Also,  in  regard  to 
rehabilitation,  we  select  various  inmates  with  disfigur- 
ing deformities — especially  of  the  face — and  through 
the  very  fine  cooperation  of  the  Director,  the  Warden, 
and  the  Plastic  Surgery  Department  of  the  University  of 
Missouri  we  are  able  to  send  these  people  home  with 
new  noses,  new  ears  and  corrected  disfiguring  facial 
scars.  And  in  conjunction  with  this  type  of  rehabilita- 
tion, th^  ■  Chief  Medical  Officer  removes  lewd  and 
obnoxious  tattoos  from  inmates  who  request  such  pro- 
cedures. 


(Centinutd  on  fagm  31) 


II 


914 


MISSOURI  STATE  PENITENTIARY 

(Continued  from  Pag»  11) 

As  an  institution  wr  contribute  to  thr  roinuiunity  by 
supplying;  whol«'  blood  tf>  tlw  tbrrr  hospitiil<i  in  I«-frcr- 
son  (lily  on  an  cnuT^^cncy  basis-  the  MrcJical  (Icntcr 
of  the  University  of  Missouri  as  well  as  our  own  needs. 
We  maintain  a  good  relationship  with  the  Red  Cross 
Blood  Bank  in  this  area  and  they  come  to  the  prison 
and  auxiliary  institutions  at  least  three  times  a  year. 
In  the  past  year  inmates  donated  over  4,.'ifX)  pints  of 
blood. 

In  conclusion,  the  main  pur|K>se  of  tlie  Medical  De- 
partment of  the  Missouri  State  Penitentiary  is  to  diagnos*- 
and  correct  any  physiological  malfunction  the  inmate 
may  have  when  he  enters;  treat  and  correct  any  injury 
or  illness  that  occurs  to  him  while  here;  and  in  general, 
to  release  him  to  society  in  the  best  possible  physical  and 
mental  condition. 

End 


915 


USE 
of 

PRISONERS 

FOR 

TvlEDICAL 
RESEARCH 

by 


Robert  W.  Hodges,  M.  D. 
WUliam  B.   Beam,   M.   D. 

The  moral  and  ethical  implications 
and  the  practical  operating  code  we 
have  developed  in  Iowa  were  de- 
scribed by  one  of  us  in  a  University 
of  London  lecture  on  July  14,  1967. 
The  basic  principles  do  not  differ  from 
those  set  forth  in  an  address  to  the 
Central  Society  for  Clinical  Research 
in  Chicago  in  1951.  Since  this  aspect 
of  our  interest  has  been  dealt  with 
elsewhere,  we  will  confine  our  com- 
ments to  the  practical  aspects  of  using 
prisoners  from  custodial  institutions 
in  Iowa  in  our  clinical  research. 

In  the  last  analysis,  the  introduction 
of  any  new  form  of  diagnosis  or  treat- 
ment, any  new  drug  or  medicine,  is  an 
experiment.  There  must  be  a  first. 
Our  problem,  therefore,  is  to  deter- 
mine to  what  degree  experimentation 
on  human  subjects  is  permissible  and 
what  should  be  the  strict  lines  of  con- 
trol and  consent.  In  recent  months  and 
years,  books  have  been  written,  sym- 
posia have  been  held,  and  hardly  a 
journal  of  clinical  investigation  has 
Dot  had  some  comments  and  ideas  on 

Nov.  —  Dec.  1967 


I »     I     m 


X. 

'-.>. , 

r 

A 

Dr. 

Beam 

the  matter.  Before  the  present  scien- 
tific explosion,  clinical  research  was 
done  by  physicians  who  were  not 
specially  trained  for  it.  Their  ex- 
perience was  that  of  general  medicine 
or  surgery.  Their  orientation  was 
practice;  their  concern  was  basically 
that  of  the  patient.  Problems  arising 
in  the  context  of  a  sick-bed  (in  the 
form  of  disease  and  its  exceptional 
behavior  in  a  puzzling  patient)  pro- 
vided incentive  enough  to  seek  solu- 
tions by  whatever  methods  were  at 
hand.  Oliver  Wendell  Holmes  and 
Semmelweis  epitomized  the  utility  of 
careful  empiricism  before  Koch  and 
Pasteur  provided  the  exact  science 
that  put  mechanisms  on  a  high  level 
of  comprehension.  Lind  knew  how  to 
prevent  scurvy  nearly  200  years  be- 
fore vitamin  C  was  discovered,  a  curi- 
ous lag  which  is  small  tribute  to  skill 
in  human  communication  of  ideas. 
Walter  Reed  had  found  out  the  man- 
ner of  yellow  fever's  spread  before  the 
causative  virus  was  understood  or 
identified.  As  one  of  us  (W.B.B.)  said 


previously: 

(Never  forget  that  the  difference  be- 
tween an  experiment  on  human  beings 
without  a  clear  understanding  and 
freely  granted  permission  and  the  de- 
termination of  the  minimum  lethal 
dose  in  man  is  one  of  degree,  not  of 
thing.  The  patient  however  humble 
and  however  ill,  in  whatever  degree 
derelict  or  forelorn,  has  sacred  rights 
which  the  physician  must  always  put 
ahead  of  his  burning  curiosity.) 

Experiments  on  human  beings  fall 
roughly  into  three  categories:  (1)  ex- 
periments done  to  test  physiological 
states  and  environmental  manipula- 
tion, both  internal  and  external,  in 
"normal"  .subjects;  (2)  the  trial  of 
new  methods,  procedures,  or  drugs  on 
persons  who  are  ill;  and  (3)  the  use 
of  doomed  patients  with  a  fatal  ilness 
to  test  potentially  dangerous  drugs  or 
procedures.  These  experiments  may 
be  either  potentially  helpful  or  of  no 
help  to  the  patient  but  possibly  may 
advance  scientific  knowledge  and 
benefit  others. 


5 


916 


It  is  unlikely  that  the  loRal  aspects 
of  pt-rrnission  to  cxpcrimont  and  a 
codified  staloniont  exactly  defining 
"informed  consent"  will  be  settled 
either  by  courts  of  law  or  by  philos- 
ophers. It  may  be  very  difficult, 
though  certainly  not  impossible,  for 
the  clinical  investigator  who  is  work- 
ing on  healthy  subjects,  as  wc  have 
been  doing  with  men  from  the  prisons 
in  the  state  of  Iowa,  to  avoid  at  least 
a  small  element  of  observer  bias  or 
parrallax.  Even  in  giving  the  possible 
description  of  the  nature  of  the  pro- 
posed experiment,  there  arc  difficul- 
ties. Wc  think  the  nature  of  the  pro- 
gram and  procedures  should  be  made 
as  explicit  as  language  and  thoughtful 
communication  can  produce.  It  is  pro- 
per to  use  a  written  consent  form. 
Certainly  the  pre  experiment  discus- 
sion should  be  available  to  volunteers 
at  any  time. 

As  will  be  pointed  out  later,  we  have 
had  a  number  of  subjects  depart  from 
the  hospital  without  permission,  but 
with  the  great  majority  of  inmates 
there  was  no  trouble.  The  very  large 
number  wishing  to  volunteer  for  sub- 
sequent studies  is  strong  evidence  that 
the  experiments  have  been  satisfac- 
tory to  the  subjects.  We  feel  justified 
in  using  our  continuing  efforts  and 
increasing  skills  in  these  difficult  and 
time-consuming  studies.  Only  in  such 
ways  can  we  gain  a  larger  grasp  of 
health-giving  and  sometimes  lifesav- 
ing  knowledge,  an  achievement  im- 
possible without  bold  and  cooperative 
subjects,  our  companions  in  medical 
science  and  adventure. 


KXPKUIK.NCK.S    IN    IOWA 

In  1949.  after  a  series  of  frustrating 
experiences,  (W.  B.  B.)  came  to 
recognize  the  need  for  a  supply  of 
normal  volunteers  who  would  be  will- 
ing to  stay  in  the  hospital  for  a  pro- 
longed period  of  time  while  under- 
going medical  studies.  At  that  time,  a 
patient  in  one  of  our  medical  wards 
had  a  chronic  skin  disorder  which  did 
not  impair  his  health.  He  was  an  in- 
mate of  one  of  the  prisons  in  Iowa, 
serving  a  life  sentence  for  murder, 
and  was  in  no  hurry  to  return  to  the 
prison.  We  were  attempting  to  study 
the  effects  of  certain  antivitamins 
upon  pantothenic  acid  metabolism,  .so 
we  seized  the  opportunity  to  admit 
him  to  our  newly  established  meta- 
bolic ward.  There  he  remained  for 
almost  a  year.  Both  he  and  we  were 
content  with  these  arrangements,  but 
when  his  prolonged  hospital  stay  came 
to  the  attention  of  prison  officials, 
they  requested  that  in  the  future  we 
not  retain  their  men  for  research  pur- 


poses without  the  knowledge  and  ap- 
proval of  the  prison.  Because  we 
needed  this  type  of  volunteer  urgently, 
wc  held  a  conference  with  officials  of 
both  prisons,  members  of  the  Board 
of  Control  which  governs  these  insti- 
tutions, and  physicians  from  several 
departments  of  the  College  of  iMedi- 
cinc  and  tnc  University  Hospitals.  As 
a  result  of  this  conference,  a  working 
arrangement  was  agreed  upon  verbal- 
ly. The  physician  who  wished  volun- 
teers was  to  send  a  written  request  to 
the  warden  who  would  then  ask  for 
those  inmates  who  wished  to  partici- 
pate in  a  particular  project.  We  knew 
that  this  procedure  was  not  specifical- 
ly permitted  by  law  but  neither  was  it 
specifically  prohibited.  But  the  law 
did  permit  the  hospitalization  of  pri- 
soners at  the  University  Hospitals  for 
treatment   of    medical    illness. 

For  a  time  things  went  well.  As  a 
result  of  this  arrangement,  we  were 
able  to  conduct  and  complete  many 
useful  investigations.  As  time  went  by, 
new  state  officials  were  puzzled  about 
this  arrangement.  On  one  occasion, 
the  state  attorney  general  was  asked 
to  rule  upon  the  legality  of  our  oper- 
ation. In  his  judgement,  it  was  not 
legal  for  us  to  accept  prison  volun- 
teers for  medical  research.  Accor- 
dingly, we  discontinued  the  use  of 
prisoners  for  research  purposes  for 
two  years.  During  this  time,  we  sought 
and  obtained  enactment  of  a  specific 
law  permitting  the  use  of  prisoners  for 
medical  research  at  the  University 
Hospitals.  This  law  states: 

(The  board  of  control  may  send  to 
the  hospital  of  the  medical  college  of 
tho  stale  university  inmates  of  the 
Idwa  sl;ile  penitentiary  and  the  men's 
rcfonii.iloiy  for  riiediciil  research  lit 
the  hospital.  lUfore  any  inmate  is 
sent  to  the  medical  college,  he  must 
volunteer  his  services  in  writing.  An 
inmate  may  withdraw  his  consnt  at 
any  time.) 

Since  enactment  of  this  law,  we 
have  availed  ourselves  of  this  valuable 
opportunity  to  conduct  clinical  inves- 
tigation in  healthy  volunteers  under 
ideal    investigative   conditions. 

One  of  the  chief  advantages  of  this 
arrangement  is  that  it  permits  selec- 
tion of  men  of  any  given  age,  height, 
and  weight.  By  screening,  the  inves- 
tigator can  select  persons  who  have  a 
specific  disorder,  such  as  diabetes 
mellitus  or  hypertension.  He  can  se- 
lect subjects  with  any  characteristic 
that  might  commonly  be  found  within 
a  prison  population.  These  subjects 
can  then  be  hospitalized  in  the  meta- 
bolic ward  under  combined  prison  re- 
search discipline  or  in  the  clinical  re- 
search center  under  similar  super- 
vision for  the  time  necessary  to  com- 
plete an  experiment. 


Wc   have  often   wondered  what  ir 
ccntivcs  and  motives  induce  prisoner-. 
to     volunteer     for     research    stud.r 
which  are  usually  .somewhat  unpU,. 
ant   and    in   a   few   instances  invo,  .e 
distinct  risks.   For  some,  it  probahl-, 
represents    a    new    experience   which 
takes  them  away  from  the  monoton; 
and  oppressiveness  of  pri.son  routine 
F'or  others,  monetary  gain  may  be  the 
incentive,    though    inmates    are   paid 
only    one    dollar    daily,    and.    under 
favorable  conditions,  they  earn  nearly 
as   much   in   prison   activities.  Prison 
volunteers    arc    less    reluctant   to  be 
visited  by  their  children  in  the  hospi 
tal  enviornment.  We  like  to  think  that 
for  .some,  a  feeling  of  altruism  moti 
vates  them  to  try  to  repay  their  debl 
to   .society.   For  a   few,   perhaps,  vol 
untcering    represents    an    opportunity 
to  escape,  and  indeed  some  have  done 
this.  For  others,  there  is  undoubtedly 
the    hope    for    more    favorable   terai 
ment  in  the   future.   Perhaps  for  ail 
there  is  a  longing  for  feminine  prox 
imity   even   though   they   realize  that 
careful  supervision  would  prevent  any 
unacceptable  behavior. 

Once  a  faculty  member  has  decided 
upon  a  project,   he  presents  his  pro- 
posal to  a  research  committee  of  the 
College    of    Medicine.    Following   the 
committee's  evaluation  and  approval, 
the  dean  sends  a  note  of  approval  to 
the  investigator  who  establishes  hai- 
son  with  the  prison  authorities  by  call- 
ing or  writing  the  director  of  penal 
institutions   on  the   Board   of  Control 
and  sends  a  copy  of  the  message  to 
the  warden  of  the  pri.son.  (There  are 
two  prisons,  the  Men's  Reformatory  at 
Anamosa.  which  houses  approximate 
ly  <;on  men  and  tlw  Inwa  .Slate  I'cni 
teiiliary      at      l-'iirl      MailiMiii.      wliii  li 
houses  ap[)roximately  1,000  men.)  Af- 
ter the  proposal  has  been  approved  by 
the  Board  of  Control,  the  warden  is 
authorized   to   present   to   the   men  a 
simple  explanation  of  the  type  of  study 
to   be   conducted    and   to   provide   an 
opportunity    for    volunteers    to    make 
themselves    known.    From   these  vol- 
unteers,  the  prison   authorities  select 
a  suitable  group  of  men  who  are  not 
emotionally   ill,    nor   habitually   unre 
liable,  nor  otherwise  unsuited  for  the 
project.    Usually  the   authorities  pro- 
vide   a    select    group    of    volunteers 
which  is  about  double  the  number  re- 
quested by  the  investigator.   The  in- 
vestigators, along  with  the  head  nurse 
of  the  metabolic  ward  and  other  auth- 
orized personnel,  then  visit  the  prison 
for  the  purpose  of  explaining  in  de- 
tail yet  simple  language  the  nature  of 
the  investigation,  the  risks  involved, 
and  the  manner  in  which  the  study 
will  be  conducted.  The  volunteers  are 
then  given  an  opportunity  to  withdraw 

Presidio 


917 


yr  to  ask  additional  quest  ions  before 
arccptiiij:.  After  the  final  selection  is 
made,  the  men  are  transported  by 
prison  authorities  to  tiie  University 
Hospitals  wliere  tliey  are  Imspitnlized 
either  on  tiie  n\etabolic  ward  or  on  the 
clinic  researcli  ward.  In  no  instance 
are  prison  research  subjects  housed 
on  the  open  wards.  After  they  arrive 
at  the  ho.spital.  they  are  given  an  ad- 
ditional detailed  briefing  and  an  op- 
portunity to  ask  additional  questions. 
Then  they  sign  a  consent  form  and 
undergo  the  customary  detailed  his- 
tory and  physical  examination  fol- 
Icwed  by  appropriate  laboratory  tests. 
The  metabolic  ward  and  the  clinical 
research  center  have  similar  rules  of 
patient  conduct,  which  include  the 
wearing  of  hospital  garb,  confinement 
to  a  given  area,  and  regulation  of 
hours  of  arising  and  going  to  bed,  use 
of  television  and  radio,  etc.  In  addi- 
tion, the  prisoner  volunteers  must  ob- 
serve certain  rules  that  prevail  at  the 
prison.  These  include  control  of  their 
correspondence  with  friends  and  rel- 
atives and  restriction  of  visitors  to  an 
approved  list  who  may  return  only  at 
.-specified  intervals.  Tiie  men  are  en- 
couraged to  enj^.ige  in  hobbies  and 
crafts,  and  they  are  required  to  par- 
ticipate in  certain  forms  of  cxesci.sc, 
such  as  supervi.scd  walks,  for  a  desig- 
hated  length  of  time  each  day.  For 
their  participation  in  research  activi- 
ties, they  receive  no  reduction  of  their 
sentences  nor  any  favoritism  regard- 
ing paroles.  We  do,  however,  send  a 


letter  to  the  warden  at  the  termination 
of  each  experiment  expressing  our 
appreciation  for  the  inmate's  partici- 
pation in  the  study.  It  is  possible  that 
this  letter  in  tlie  prisoner's  file  may 
favorably  influence  the  parole  board. 

Since  our  first  patient,  who  was  an 
unofficial  volunteer,  we  have  accepted 
a  total  of  224  prisoners  for  medical 
research  at  University  Hospitals.  Only 
a  few  of  these  represent  "repeaters" 
since  we  try  to  avoid  selecting  a  man 
more  than  once.  Most  of  the  men 
have  been  housed  on  the  metabolic 
ward,  but  a  substantial  number  have 
been  studied  in  the  clinical  research 
center.  Of  the  total,  ten  have  escaped. 
Most  of  the  escapees  were  subjects  for 
the  medical  experiment  who  had  been 
selected  rather  hastily  at  the  insis- 
tance  of  an  investigator:  hence  prison 
officials  had  not  been  given  ample 
opportunity  to  make  their  usual  care- 
ful selection. 

The  level  of  compliance  by  pris- 
oners with  research  rules  and  regula- 
tions has  been  surprisingly  high.  They 
have  eaten  strange  diets,  swallowed 
tubes,  submitted  to  repeated  veni- 
punctures, and  participated  in  a  wide 
variety  of  psychological  tests  with  a 
commendable  degree  of  good  humor 
and  cheerfulness.  Although  any  man 
may  leave  the  study  to  return  to  the 
prison  if  he  so  desires,  this  has  hap 
pened  in  very  few  instances.  There 
have  been  some  personal  problems 
and  some  instances  of  disappointmer;' 
on  the  part  of  the  prisoners,  but  most 


of  the  men  seem  to  feel  they  have  per- 
formed a  useful  service  by  participat- 
ing. The  research  studies  conducted 
on  prison  volunteers  have  yielded  im- 
portant results.  Vitamin  deficiencies 
have  been  characterized,  antibody  re- 
sponses studied,  and  important  as 
pects  of  fat  and  cholesterol  metabol 
ism  clarified.  More  than  80  scientific 
publications  have  resulted  from  the.>c 
studies.  We  feel  that  the  use  of  prison 
volunteers  for  medical  research  is 
justified  and  highly  desirable  for  the 
investigator,  for  the  subjects,  and  for 
society.  It  not  only  permits  the  con- 
duct of  human  investigation  under 
ideal  circumstances,  but  it  enables  the 
participants  to  feel  that  they  arc 
serving  a  useful  function  as  indeed 
they  are. 

SUMMARY 

A  system  of  voluntary  participation 
firmly  based  on  legal  and  ethical 
standards  has  provided  a  rich  oppor- 
tunity for  clinical  investigators  v/ho 
wish  to  study  metabolic,  psysioligic. 
pharmacologic,  and  medical  prob- 
lems. This  has  been  a  rewarding  ex- 
perience both  for  the  physicians  and 
for  the  subjects. 

(From  the  Department  of  Intcrr>ul 
Medicine,  University  Hospitals.  Uni- 
versity of  Iowa,  Iowa  City.  Reprint  re- 
quests to  University  Hospitals,  Uni- 
versity of  Iowa,  Iowa  City,  Iowa  52241 
—  Dr.  Hodges). 


WHY  PRISONERS  VOLUNTEER 

TO  BE  EXPERIMENTAL  SUBJECTS 


John  C.  McDonald,  MD 


Recently,  while  engaged  in  a  clinica\ 
experiment  involving  inmates  of  a 
nearby  state  prison,  I  became  rather 
perplexed  by  the  reaction  of  col- 
leagues to  the  program.  There  was 
considerable  interest  in  why  inmates 
subjected  themselves  to  such  exper- 
imentation. The  question  most  fre- 
quently raised  concerned  what  re- 
wards were  given  to  such  volunteer.;, 
and  the  prevailing  attitude  seemed  to 
be  that  this  was  a  group  of  men  who 
were  simply  being  exploited,  albeit 
for  a  good  cause.  This  attitude  is  un- 
derstandable coming  from  one  whose 
viewpoint  stems  from  a  rather  com- 
fortable position  in  society,  but  Ui'j 
view  is  entirely  different  when  it 
comes  from  within  the  walls  of  prison. 

In  the  flurry  of  current  concern  over 
the  proper  ethical  guidelines  of  hum- 


an experimentation,  the  rights  of  the 
subject  to  be  protected  have  received 
attention  as  has  the  right  of  society 
for  progress.  I  have  not  seen  any 
discussion  of  the  right  of  the  volunteer 
(particularly  the  inmate  volunteer)  to 
volunteer. 

The  inmate  does  not  volunteer  be- 
cause he  expects  his  sentence  to  be 
shortened,  nor  does  he  volunteer  for 
financial  reward.  Actually,  he  does  so 
for  much  more  immediate  reasons, 
which  are  quite  apparent  to  him  and 
which  seem  quite  sound. 

The  fact  that  the  inmate  does  recog- 
nize advantages  in  these  programs  is 
attested  to  by  his  eagerness  to  parti- 
cipate in  them  as  well  as  by  his 
willingness  to  persevere  unto  the  end. 
in  spite  of  morbidity. 


For  the  experiment  which  occa- 
sioned these  reflections,  2,000  men 
were  given  a  prepared  circular  calling 
for  participants.  In  three  days  there 
were  approximately  350  petitions  sub- 
mitted. Since  no  more  petitions  were 
accepted  thereafter,  the  number  of 
volunteers  who  eventually  would  have 
applied  remains  unknown.  Further,  of 
the  50  men  eventually  accepted  for  an 
experiment  which  required  three  suc- 
cessive skin  allografts  over  a  period 
of  12  weeks,  there  was  only  one  man 
who  dropped  out  of  the  program  of  his 
own  accord. 

To  understand  this  phenomenon 
some  consideration  from  the  pris- 
oners*  view   is   required. 

The  image  of  the  medical  profession 
still  stands  largely  unblemished  to  the 
inmate,  and  as  a  result  he  accepts  as 


Nov.  —  Dec.   1967 


93-999  O  -  73  -  pt.  3  — 


918 


an  nrticlc  of  faitli  the  <nxiom  that  a 
physician  would  not  ask  him  to  subject 
iumsclf  to  risks  that  were  not  justi- 
fied. This  faith  places  enormous  re- 
sponsibility upon  tiie  investigator  and 
is  the  principal  reason  that  some  pro- 
tective procedures  are  necessary. 
Nevertheless,  while  this  faith  burdens 
the  investigator,  it  frees  the  inmate  to 
volunteer  for  more  personal  advanta- 
ges. 

Volunteering  is  an  opportunity  to 
break  the  monotony  of  his  life.  Prison 
life,  as  it  exists  today,  is  quite  stereo- 
typed. Life  is  regimented.  One  arises 
at  a  specified  time,  performs  specific 
tasks  in  specified  clothes  under  spec- 
ified conditions,  cats  .specified  foods, 
.sees  visitors  at  specified  times,  and 
even  writes  letters  under  specified 
conditions. 

It  would  be  unfair  to  the  Depart- 
ment of  Corrections  of  the  State  of 
New  York  to  imply  that  many  oppor- 
tunities are  not  available  to  inmates 
to  occupy  their  time  and  to  provide  for 
their  self-improvement.  Every  effort 
is  made  to  interest  the  inmate  in  such 
programs.  Nevertheless,  many  do  not 
respond.  To  these  inmates,  life  is 
basically  a  bore,  and  one  day  is  quite 
like  another.  The  experiment  breaks 
this  boredom  and  as  such  ia  refresh- 
ing. It  also  introduces  a  note  of  excite- 
ment into  prison  life.  Man  in  general 
needs  some  stimulation.  The  state  of 
total  security  in  which  these  men  find 
themselves  becomes,  after  a  while, 
both  unhealthy  and  unpleasant.  The 
experiment,  in  the  sense  that  it  in- 
cludes an  element  of  the  unknown  and 
an  element  of  personal  risk,  tempor- 
arily relieves  this  condition.  Many  of 
the  men  verbalize  these  motives  with 
their  expression:  "It  (the  experiment) 
breaks  the  time." 

The  inmates  enjoy  being  involved  in 
positive  action.  They  are  "doing  some- 
thing" and.  just  as  important,  they 
have  something  to  talk  about.  Conver- 
sation turns  rather  stale  in  prison, 
and  subjects  of  genuine  interest  are 
scarce.  Each  day  an  inmate  sees  the 
same  people  he  saw  yesterday,  and 
they  haven't  done  anything  that  he 
hasn't  done.  Consequently,  conversa- 
tion eventually  degenerates  into  what 
the  inmate  calls  "prison  gossip".  The 
men  in  the  experiment,  however,  had 
an  item  of  conversation.  Not  only  did 
they  have  an  item  of  conversation, 
they  were  an  item  of  conversation. 
The  volunteers  were  subjects  of  in- 
terest to  the  entire  prison,  not  only  to 
the  other  inmates,  but  also  to  employ- 
ees of  the  prison  at  all  levels.  People 
inquired  of  the  experiment's  progress, 
what  was  being  required  of  the  in- 
mates as  volunteers,  and  what  was 
being  learned.  As  they  conversed,  the 
volunteers  found  that  they  were  no 

8 


longer  nonentities.  Suddenly,  they 
were  inmportant!  They  became,  at 
least  for  a  while,  the  elite  of  their  own 
society. 

Consequently,  the  experiment  also 
serves  to  strengthen  the  ego.  The  in- 
mate has  been  singularly  unsuccessful 
and  has  ultimately  found  himself  in 
society's  lowest  estate.  Being  a  pris- 
oner undoubtedly  is  one  of  the  most 
severe  tests  of  ego  structure  yet  de- 
vised. It  is  extraordinarily  difficult  to 
maintain  a  sense  of  one's  own  per- 
sonal value  under  such  conditions.  The 
experiment  offers  an  opportunity  for 
the  inmate  to  prove  to  himself  or  to 
his  friends  and  relations  that  he  can 
do  something  worthwhile.  Participat- 
ing in  the  experiment  requires  risk; 
ic  requires  sacrifice,  perseverance, 
and  altruistic  ideals.  Such  behavior 
improves  his  own  self-esteem  and 
elevates  his  status  in  the  eyes  of  those 
who  are  important  to  him. 

The  inmate  has  a  real  desire  to  be  a 
part  of  society  at  large,  and  the  ex- 
periment provides  this  opportunity 
since  it  originates  from  the  "outside". 
The  inmate  also  wishes  to  have  the 
opportunity  to  relate  to  people  from 
the  outside.  Once  he  becomes  ac- 
quainted with  the  investigative  per- 
sonnel, he  frequently  seeks  advice 
from  them  on  many  subjects.  Appar- 
ently, this  is  due  to  his  deep-seated 
distrust  of  anyone  associated  with  the 
correction  system.  The  investigators, 
having  no  such  connection,  are  not 
automatically  suspect  and.  therefore. 
their  opinions  are  held  in  higher 
esteem. 

(The  following  exerpt  is  from  a  let- 
ter written  by  an  extremely  intelli- 
gent, 27-year-old  man  serving  a  life 
sentence.  I  quote  with  his  permission: 

A  former  warden  once  said,  "The 
strongest  desire  of  most  men  in  prison 
is  to  be  able  to  take  part  in  outside 
activities."  I  agree  with  this,  adding 
however,  that  this  goes  double  when 
there  is  a  possibility  of  being  of  bene- 
fit to  humanity. 

I'd  like  to  say  further  that  it  was 
a  very  interesting  twelve  weeks.  If 
you  ever  have  any  complfiints  about 
your  bedside  manner,  just  remember 
your  boys  here,  with  whom  your  corn- 
pone  humor  made  the  scapel  and 
needle  work  something  to  look  for- 
ward to." 

If  these  motives  are  discussed  with 
inmates,  they  readily  accept  them  as 
being  valid.  The  inmates  maintain, 
however,  that  in  addition  they  vol- 
unteer simply  because  it  is  a  good 
thing  to  do.  In  a  spontaneous  discus- 
sion with  some  ten  of  the  group,  they 
pointed  out  rather  articulately  that 
circumstances  make  them  the  logical 
persons  to  perform  such  tasks.  They 
do  not  have  the  responsibilities  of  a 


job.  nor  do  they  .support  a  family.  \r, 
one  is  dependent  upon  them  who  ha' 
not  already  adjusted  to  doing  withoi;' 
them.  They,  therefore,  feel  justified 
in  accepting  risks  for  the  common 
good  which  they  themselves  would  not 
accept  if  they  were  outside. 

Finally,  the  group  of  men  became  a 
group.  As  a  genuine  espirt  de  corps 
developed,  they  became  interested  noi 
only  in  themselves,  but  also  in  each 
other.  Their  attentions  were  diverted 
from  their  own  problems  to  those  of 
the  group  and  of  the  experiment.  The 
volunteers  became  interested  in  the 
entire  subject  of  transplantation  and 
began  to  read  and  to  suggest  ideas. 
They  helped  to  make  the  mechanics 
of  the  experiment  run  more  smoothly. 
If  a  light  faltered,  it  was  quickly  ^^ 
paired.  If  a  man  faltered,  he  was  en- 
couraged (not  always.  I'm  afraid,  by 
unadorned  rhetoric).  The  volunteers 
even  selected  a  name  for  the  group. 
Transplant  Experiment  Attica  was 
considered  (to  be  called  TEA),  but  the 
contraction  was  not  agreeable.  They 
finally  settled  upon  Skingraft.  Attica 
Group,  Experiment  (to  be  referred  to 
as  the  SAGE  group,  or  the  SAGE 
sera). 

Certainly  they  enjoyed  the  entire 
process.  Most  expressed  regret  when 
it  was  completed,  and,  to  a  man,  they 
wished  to  be  kept  informed  of  the  pro- 
gress of  the  laboratory  studies. 

This  report  has  been  written  with 
considerable  misgiving  caused  by  the 
fear  of  being  misunderstood.  The  ben- 
efits to  the  inmate  discussed  here  arc 
not  being  proposed  as  justification  for 
experiments.  Obviously,  this  is  ab- 
surd. Rather,  the  report  has  been 
written  to  point  out  that  the  inmate 
is  not  a  neutral  quantity,  nor  is  he 
exploited  by  proper  experiments.  He 
volunteers  for  certain  advantages  that 
are  clear  to  him,  and  he  continues 
because  these  desires  are  largely 
fulfilled. 

As  the  guidelines  of  human  exper- 
imentation evolve,  it  is  to  be  hoped 
that  the  inmate's  point  of  view  will 
not  be  ignored. 

(The  experiments  referred  to  were 
performed  at  Attica  (NY)  State  Pris- 
on, with  the  consent  of  the  Commis- 
sioner of  Correction  of  the  State  of 
New  York.  Paul  D.  McGinnis.  Advice 
was  provided  by  Warden  Vincent  R. 
Mancusi  and  assistance  by  Senior 
Physician,  S.  T.  Williams.  Jr.,  MD) 

(From  the  State  University  of  New 
York  at  Buffalo  and  Edward  J.  Meyer 
Memorial  Hospital,  Buffalo. 

Reprint  requests  to  462  Grider  St.. 
Buffalo  14215  (Dr.  McDonald)  JAMA. 
Nov.  6.  1967  (Vol.  202.  No.  6) 


Presidio 


919 


Our  Medical  Debt  To  Prisoners 


by  Webb  Garrison 


(Roprinled  from  the  Catholic  Dif;cst) 

While  he  waited  for  death  in  an  Oklahoma  prison, 
a  convicted  murderer  agreed  to  test  doses  of  a 
new  drug.  Months  after  his  execution,  the  knowiedfie 
doctors  pained  saved  a  woman's  life.  Someone  in 
your  family  could  be  in  debt  to  people  like  him,  for 
|)ris()ners  have  made  an  enormous  contribution  to 
medical  research. 

Louis  Pasteur  (died  1895)  once  suggested  to  the 
emperor  of  Brazil  that  prisoners  be  invited  to 
undergo  inoculation,  exposure,  and  treatment  in  the 
fight  against  yellow  fever,  but  was  refused.  In  1915 
Dr.  Joseph  Goldberger,  a  U.  S.  public-officer,  was 
studying  pellagra,  which  has  effects  somewhat  like 
those  of  leprosy.  It  was  endemic  in  many  parts  of 
the  U.  S.,  and  claimed  100,00  new  victims  each 
year.  Goldberger  thought  it  an  effect  of  dietary 
deficiencies,  and  suggested  that  prisoners  volunteer 
to  prove  his  theory. 

Doctors  and  the  general  public  thought  no  pri- 
soners would  ever  volunteer,  and  scoffed  at  his 
suggestion.  The  Governor  of  Mississippi  gave  him 
permission  to  ask  long-term  convicts  to  risk  develop- 
ing pellagra  in  return  for  a  pardon.  Twelve  healthy 
white  convicts  accepted  the  terms.  With  their  diet 
restricted  largely  to  carbohydrates,  half  of  them 
developed  pellagra  within  six  months. 

The  tests  led  to  victory  over  pellagra,  and  rallied 
public  support  for  food  and  drug  laws.  It  also  estab- 
lished the  fact  that  prisoners  were  willing  to  risk 
their  lives  for  mankind,  so  some  drug  manufacturers 
launched  and  expanded  programs  of  prisoner  test- 
ing. 

Military  demands  of  the  2nd  World  War  created 
su«"h  u  sliorlji;',**  of  blood  plnsmn  th;it  navy  doctors 
fell  n;ilion;il  security  was  at  stake.  Tlicy  developed 
a  plasma  substitute  made  from  the  blood  of  cattle. 
On  paper  and  in  the  laboratory  it  looked  good,  but 
they  had  to  test  it  upon  humans,  whose  reactions 
are  sometimes  radically  different  from  those  of  ir- 
rational animals. 

In  1942,  naval  officers  appealed  to  inmates  of  the 
State  Prison  colony  at  Norfolk,  Mass.  Though  the 
extreme  risks  involved  were  carefully  outlined,  222 
of  the  750  inmates  volunteered,  and  64  were  select- 
ed. Each  man  received  an  injection  of  a  purified 
fraction  of  beef  blood.  There  were  no  immediate 
effects,  but  within  a  month  one  man  died,  eight  had 
high  fever,  and  a  dozen  others  were  ill.  Governor 
Saltonstall  gave  a  posthumous  pardon  to  Arthur  S. 
Germain  and  the  experiment  was  stopped,  but  over 
the  protest  of  some  volunteers  who  had  not  yet  re- 
ceived their  injections. 

Since  then,  hundreds  of  prisoners  have  voluntarily 
contracted  painful  maladies.  But  the  death  rate  is 
close  to  zero  because  the  way  the  tests  are  conduct- 
ed makes  participation  safer  than  crossing  the 
street. 


Still  it  has  involved  great  discomfort.  At  Holme.s- 
burg  pri.son,  in  Philadelphia,  a  test  of  diet's  effect 
on  cholesterol  requi-ed  60  men  to  go  ten  months 
without  eating  anything.  They  drank  a  special  emul- 
sion three  times  a  day  and  only  two  men  broke  the 
diet.  Hundreds  of  other  prisoners  have  suffered  the 
chills  and  high  fever  of  malaria  in  experiments  that 
have  been  in  progress  since  1944. 

Volunteers  behind  bars  have  made  major  con- 
tributions to  the  study  of  malaria,  polio,  cancer, 
diabetes,  hepatitis,  drug  addiction,  German  measles, 
industrial  radioactivity,  gonorrhea,  headaches,  tu- 
berculosis, influenza,  schizophrenia,  syphilis,  hay 
fever,  leukemia,  acne,  tetanus,  cerebral  palsy,  and 
cardiovascular  disease. 

The  federal  government  now  sponsors  medical 
research  in  about  half  of  its  37  penal  institutions. 
It  is  conducted  under  the  direction  of  the  U.  S.  Pub- 
lic Health  service,  and  involves  more  than  3,000 
men  a  year.  Experiments  are  also  conducted  in 
prisons  of  at  least  a  dozen  states.  Even  municipal 
systems  are  involved,  Inmates  of  Cook  County  jail, 
Chicago,  volunteered  to  take  injections  from 
leukemia  victims.  At  Philadelphia's  Holmesburg  pri- 
son, 90%  of  the  1,500  inmates  take  part  in  ex- 
periments. Some  require  participants  to  be  burned 
on  each  arm  by  a  carbon-arc  lamp.  One  set  of  burns 
is  dressed,  the  other  left  untreated  in  an  attempt  to 
measure  how  good  drugs  and  poultices  are. 

At  Ohio  State  penitentiary,  Columbus,  inmates 
permitted  scientists  of  the  Sloan-Kettering  institute 
to  inject  about  3  million  active  cancer  cells  into  their 
forearms.  Nodules  (lumps)  appeared  in  the  flesh  of 
most  subjects,  but  disappeared  within  two  to  three 
weeks.  Newspapers  in  communist  countries  pro- 
tested, and  a  ('oimeeticiit  scientist  (.•illed  the  ex[>eri- 
meiit  an  "impairment  of  human  dignity".  Hut  |);«r- 
ticipants,  who  ranged  in  age  from  26  to  56,  told  of 
friends  and  relatives  who  had  died  of  cancer,  and 
said  they  were  proud  to  have  a  part  in  fighting  it. 

More  than  20  viral  infections  have  been  studied  at 
the  National  Institutes  of  Health  in  Bethesda,  Md. 
Minimum-custody  prisoners,  who  volunteer,  are 
brought  to  a  research  hospital  for  about  a  month. 
Officers  from  the  Bureau  of  Prisons  supervise  them. 
Since  1960  more  than  1,000  men  have  taken  part  in 
this  program.  Results  were  reported  in  the  "Journal 
of  Immunology"  and  other  technical  publications. 

From  the  viewpoint  of  the  investigators,  the  ad- 
vantages of  using  prisoner  volunteers  are  enormous. 
Prisoners  all  eat  the  same  food  and  sleep  the  same 
hours.  They  are  always  available  for  observation.  A 
prison  is  an  ideal  place  for  projects  that  involve  use 
of  large  numbers  of  subjects  over  long  periods  of 
time. 

Dr.  Henry  Beecher  of  the  Harvard  Medical  School 
thinks  that  prisoners  should  not  be  used  in  experi- 
ments.  "Wherever  possibilities  for  coercion  exist, 


—10- 


920 


however  subtle  they  may  bo,"  he  says,  "the  use  of 
sucli  a  Rroup  usually  violates  the  requirements  for 
valid  consent.  An  award  by  reduction  in  time  of  im- 
prisonment is  really  an  almost  overwhelming  bribe 
which  violates  the  requirements  of  the  principle  of 
consent." 

Few  penal  authorities  or  prisoner  volunteers  sup- 
l)()rt  him.  Rewards  vary  from  one  institution  to 
another,  but  are  generally  very  small.  In  return  for 
participation  in  hepatitis  tests,  533  inmates  of  feder- 
al prisons  received  a  30-day  reduction  of  their  sen- 
tences, plus  30(t  a  day  for  the  term  of  the  experi- 
ment. More  than  one  fourth  of  them  contracted  hepa- 
titis. 

There  is  no  known  cure  for  rabies,  yet  at  Louis- 
iana's Angola  pri.son  46  men  volunteered  to  test  in- 
oculations with  no  reward  offered.  Ohio  State  pcni- 
lenliary  gives  no  rewards  to  volunteers,  but  always 
hiis  more  than  needed.  At  Sing  Sing,  62  men,  who 
voluiilcrred  to  contract  syphilis  by  means  of  injec- 
tions, knew  in  advance  that  they  would  get  no  re- 
ward t>xee|)t  an  entry  on  their  records  and  .some 
small  gifts. 

The  men  who  participated  in  Joseph  Goldberger's 
1915  pellagra  tests  were  given  full  pardons.  Today's 
prisoners  who  volunteer  for  experiments  may  get 
nothing  more  than  "good  time"  privileges,  a  few 
dollars'  spending  money,  and  a  certificate  of  ap- 
preciation. Though  few  would  use  the  vocabulary  of 
religion  to  express  their  feelings,  many  offer  them- 
selves as  experimental  subjects  as  a  way  of  doing 
penance. 

The  volunteers  get  some  indirect  benefits.  Inmate 
technicians  learn  skills  which  increase  their  chances 
of  finding  work  when  released.  Two  well-paid  work- 
ers at  a  major  Midwestern  university  came  from  the 
penitentiary  at  Joliet.  Another  ex-prisoner  from  the 
same  institution  now  supervises  a  staff  of  lab  tech- 
nicians at  a  southern  college.  Even  before  serving 
their  time  and  gaining  their  freedom,  some  men  are 
certified  by  the  American  Board  of  Medical  Tech- 
nicians. 

Men  who  take  part  in  tests  in  prisons  get  a  physi- 
cal examination  that  would  cost  about  $500  outside. 
At  Jackson,  Michigan,  nearly  half  who  offer  their 
.services  are  eliminated  as  a  result  of  their  physicals. 
Supervisors  have  drawn  up  an  elaborate  code  de- 
fining permissable  medical  exF>eriments.  Some  of 
them  quote  a  1952  statement  by  Pius  XII:  "Man's 
personal  being  is  not  intended,  in  the  last  analysis, 
for  the  use  of  society;  but,  on  the  contrary,  society 
is  for  men." 

In  keeping  with  that  principle,  federal  authorities 
limit  volunteers  to  men  in  good  physical  condition 
with  enough  emotional  stability  to  let  them  take  part 
in  tlie  study  without  suffering  mental  upset.  Before 
a  test  is  made,  the  men  are  told  of  the  hazards,  dis- 
comforts, and  inconveniences  they  face.  Volunteers 
are  free  to  drop  out  any  time.  Upon  completion  of  a 
test,  participants  are  given  complete  examinations 
and  are  released  from  medical  care  only  when  they 
are  free  from  all  ill  effects. 

The  programs  should  expand.  Today's  drugs  are 
more  |M>lcnt  than  ever.  There  is  more  danger  of  un- 


known side  effects,  and  tests  upon  humans  have 
greater  importance.  Strict  testing  and  reporting  is 
now  exacted  before  a  new  drug  can  be  placed  on  the 
market. 

In  1964  the  Michigan  Board  of  Corrections  with  the 
Upjohn  Co.,  and  Parke-Davis  Co.  designed  a  com- 
plete drug-testing  facility,  then  built  it  inside  the 
walls  of  Jackson  State  prison  at  a  cost  of  more  than 
$500,000.  Prisoners  participate  in  the  tests,  and  per- 
form many  jobs  in  the  laboratory  and  hospital. 

The  testing  of  anesthetics,  tranquilizers,  steroids, 
analgesics,  and  anticoagulants  in  the  Jack.son  pro- 
gram is  a  dream  come  true.  Experts  say  it  will 
enable  research  workers  to  detect  and  discard  un- 
suitable drugs  within  a  few  weeks  or  months,  in.stead 
of  three  to  five  years.  We  are  all  in  debt  to  the 
volunteers  in  pri.son. 


-11- 


921 


The  Research  Clinic  inside  the  Southern  Michigan  State  Prison. 


In  1964  the  State  of  Michigan  through  its  Department  of  Corrections 
established  an  unbiased  Research  Protocol  Review  Committee  which  has 
functioned  for  the  State  as  a  scientifically  knowledgeable  peer  review  and 
advisory  committee  concerning  human  research  in  the  prison  population. 
Policies  for  clinical  research  involving  volunteers  from  the  prison  popula- 
tion were  firmly  established.  The  unique  cooperation  of  existing  state  agen- 
cies and  the  medical  colleges  permitted  the  formation  of  an  over-all  advisory 
committee  which  included  representatives  of  the  State  Department  of  Cor- 
rections, the  State  Health  Department,  and  the  two  Michigan  Medical 
Colleges.  The  establishment  and  functioning  of  the  Research  Protocol  Re- 
view Committee  are  described.  After  the  committee  was  established  Phase 
I  studies  were  permitted  within  the  prison  population.  Since  the  formation 
of  the  Research  Protocol  Review  Committee,  in  several  hundred  Phase  I 
and  other  studies,  no  serious  adverse  reaction  has  yet  occurred. 


A   Research    Protocol   Review   Committee 
For  the   State   of  Michigan 


BY  ROSS  V.  TAYLOR,  M.D.,  JACKSON 
CHRIS  J.  D.  ZARAFONETIS,  M.D.,  ANN  ARBOR 
EDWARD  A.  CARR,  JR.,  M.D.,  ANN  ARBOR 
LAWRENCE  H.  POWER,  M.D.,  DETROIT 
PARK  W.  WILLIS,  III,  M.D.,  ANN  ARBOR 
PHILIP  A.  RILEY,  JR.,  M.D.,  JACKSON 


During  the  past  few  years  new  regulations  have 
led  to  a  marked  increase  in  the  influence  oi  the 
Food  and  Drug  Administration  on  the  study  and 
use  of  drugs  in  this  country.  While  some  prob- 


lems remain  to  be  resolved,  the  pharmaceutical 
industry,  the  academic  community  and  practicing 
physicians  have,  for  the  most  part,  made  excellent 
progress  towards  a  satisfactory  adjustment  to  these 
new  regulations. 

Unfortunately,  it  now  appears  that  this  com- 
plex system  may  be  further  complicated  by  legisla- 
tive action  at  the  state  or  national  level.  Legisla- 
tion introduced  in  the  New  York  State  Legfisla- 
ture  last  year  would  have  established  a  State  Com- 
mission with  authority  to  control  all  research  in- 
volving human  subjects.*  It  was  proposed  that  this 
Commission    on    Medical    Research    consist    of   a 


MICHIGAN  MEDICINE    OCTOBER  1969    1023 
Reprinted  from  MICHIGAN  MEDICINE,  Vol.  68.  No.  19,  Pages  1023-1028,  October,  1969 


922 


PROTOCOL  RESEARCH/Continued 

chairman,  appointed  by  the  Governor,  and  11 
other  members.  The  act  further  provided  that  "not 
less  than  six  of  those  11  other  members  shall  at 
all  times  be  non-members  of  the  medical  profes- 
sion." The  implications  of  such  legislaticm  are 
far-reaching  and  of  concern  to  all  who  are  re- 
sponsible for  developments  in  clinical  pharma- 
cology and  theraf>eutics.  The  New  York  State  pro- 
posal would  have  placed  control  of  human  re- 
search in  the  hands  of  "non-members  of  the 
medical  profession."  It  would  also  have  created 
an  administrative  and  review  mechanism  which 
would  intrude  on  the  area  of  resfKwisibility  and 
authority  of  hospital  directors  and  professional 
staffs,  deans  of  medical  schools  and  their  faculties 
(including  their  respective  Committees  to  study 
Clinical  Research  and  Investigation  Involving  Hu- 
man Beings,  and  which  follow  guidelines  set  forth 
by  the  Public  Health  Service)  and  prison  com- 
missioners and  their  boards  in  those  situations 
where  inmates  volunteer  to  participate  in  such 
studies.  Chaos  would  result  should  all  50  states 
create  differing  laws  regulating  research  on  hu- 
man beings. 

ON  THE  NATIONAL  SCENE  the  recent  prob- 
lems disclosed  in  the  New  York  Times,  May  31, 
1969,  concerning  the  necessity  for  the  Alabama 
Board  of  Corrections  to  order  a  halt  to  the  drug 
testing  programs  being  conducted  in  the  state 
prisons,  resulted  in  wide-spread  adverse  publicity 
and  editorials  concerning  drug  testing  and  re- 
search throughout  the  nation. 

The  Medical  World  News  in  the  August  29, 
1969  issue,  page  13,  states:  "Partly  as  a  result  of 
recent  'disclosures'  in  the  New  York  Times,  most- 
ly a  rehash  of  earlier  stories  in  the  Montgomery 
(Ala.)  Advertiser,  and  a  critical  report  by  the 
Medical  Association  of  the  State  of  Alabama,  FDA 
Commissioner  Herbert  L.  Ley,  Jr.,  was  called  be- 
fore the  Senate  Monopoly  Subcommittee  of  Sen. 
Gaylord  Nelson  (D.-Wis.) .  Dr.  Ley  testified  that 
the  agency  would  seek  to  have  exf>ert  reviewers 


Part  of  the  laboratory  and  examining  rooms  of 
the  special  facility  for  research  projects  at 
Southern  Michigan  State  Prison. 


examine  protocols  at  prisons  and  other  institu- 
tions conducting  drug  studies  and  monitor  the 
evaluations." 

In  the  American  Medical  News  August  25,  1969 
it  was  repx>rted  that  Dr.  Ley  in  questioning  by  a 
Senate  Small  Business  Subcommittee  stated  that 
he  planned  "to  issue  a  regulation  requiring  that 
drug  testing  in  prisons  and  hospitals  be  screened 
by  'p)eer  groups'  of  physicians,  lawyers,  and  clei^- 
men." 

Senator  Nelson  has  introduced  a  bill  that  would 
create  a  federal  center,  under  FDA  auspices,  to  do 
all  such  work. 

THESE  COMMENTS  are  not  to  be  construed 
as  criticism  of  the  Legplslature  of  the  Common- 
wealth of  New  York,  which  is  properly  attemp>ting 
to  assure  maximum  protection  for  those  p>ar- 
tid{>ating  as  subjects  in  human  research.  In  New 
York,  Alabama,  and  in  many  other  states,  there 
appears  to  be  a  need  for  some  means  by  which 
drug  investigation  in  humans  can  continue  with 
adequate  safeguards  for  volunteer  subjects  outside 
of  university  medical  centers.  At  the  present  time 
all  university  medical  centers  and  most  hospitals 
where  research  involving  human  beings  is  per- 
formed have  review  committees  assigned  this  re- 
sp>onsibility.  But  there  remains  a  large  g^up  of 
normal  volunteers,  often  prisoners,  for  whom  simi- 
lar sup)ervision  and  protection  must  be  provided. 
However,  the  placement  of  research  guidance  un- 
der uninformed  laity  would  seem  ill-advised  and 
impractical. 

The  State  of  Michigan  has  provided  safeguards 
for  over  five  years  for  its  Department  of  Correc- 
tions through  its  Protocol  Review  Committee. 
This  description  of  the  history  and  function  of 
the  Committee  is  presented  here  in  the  hope  that 
it  may  be  help>ful  to  others  searching  for  a  means 
of  dealing  with  this  problem. 

BACKGROUND 

The  effective  use  in  preceding  years  of  vcrfun- 
teers  from  the  prison  populaticm  for  human  re- 
search at  the  Southern  Michigan  State  Prison  led 
to  the  suggestion  by  the  Upjohn  Company  in  1961 
that  a  research  facility  be  constructed  inside  the 
prison.  This  suggestion  was  of  interest  to  the  De- 
p>artment  of  Corrections  because  serious  sp>ace 
problems  had  limited  the  research  programs  that 
could  be  conducted  in  the  prison  hospital.  In 
November,  1961,  Harold  L.  Upjohn,  M.D.  and 
William  N.  Hubbard,  Jr.,  M.D.,  Dean  of  the 
University  of  Michigan  Medical  School,  met  with 
the  Corrections  Commission  of  the  State  of  Mich- 
igan and  outlined  proposals  for  the  general  re- 
search program  and  for  the  construction  of  a 
Medical  Research  Building  within  the  Southern 
Michigan  State  Prison.^ 

In  December,  1961,  the  Corrections  Conunission 


1024    MICHIGAN  MEDICINE    OCTOBER  1969 


923 


approved'  in  principle  recommendations  relative 
to: 

1.  Construction  of  a  facility. 

2.  Participation   of  inmates.   Guidelines  stated 
that  participation  must: 

a.  Be  voluntary  in  all  instances. 

b.  Be  based  upon  informed  consent.  An 
agreement  between  each  volunteer  and 
The  Upjohn  Company  informing  the  in- 
mate of  the  nature  of  his  participation 
and   the  possible  associated  hazards. 

c.  Include  the  right  to  voluntary  withdrawal 
from  a  study  at  any  time. 

d.  Stipulate  the  rate  of  compensation  for 
volunteers. 

e.  Be  based  on  the  non-discriminatory  in- 
mate participation  policy. 

3.  Waiver  of  liability  on  the  part  of  the  State, 
the  Commission,  and  its  employees. 

4.  Liability  insurance. 

5.  Sf>ecial  diet  responsibilities. 

6.  Prop>osed  research  project  review  procedure. 

7.  Cost  of  construction. 

8.  Possession  of  title  of  the  building. 

9.  Professional  staff  and  custodial  control. 

In  April  1%2,  the  Corrections  Commission  asked 
the  Director  of  the  Department  of  Corrections 
to  inform  the  Parke,  Davis  Company  that  the 
Department  was  proceeding  with  the  Upjohn  Pro- 
posal,* and  in  May  advised  the  Director  to  pro- 
ceed with  the  Upjohn  Project.^  In  August,  the 
Director  reported  to  the  Commission  that  meetings 
had  been  held  with  the  architect  to  initiate  plan- 
ning for  the  construction  of  a  Research  Building.* 
In  March,  1963,  the  Commission  reviewed  the  re- 


quest of  the  Parke,  Davis  Company  to  join  The 
Upjohn  Company  in  the  construction  of  the  Re- 
search Building  and  recommended  to  the  Director 
that  the  request  be  approved.^ 

EARLY  IN  1964,  Harold  L.  Oster,  M.D.,  an 
Upjohn  Company  research  investigator,  and  Har- 
old L.  Upjohn,  M.D.,  became  concerned  that  the 
only  review  of  research  protocols  was  within  the 
research  department  of  the  Comp>any.  An  unbiased 
review  mechanism  seemed  desirable  for  several 
reasons  including  a  desire  to  improve  the  safety 
factors  of  volunteers  for  the  studies,  and  also  the 
recognition  of  the  problem  that  in  the  advent  of 
an  adverse  drug  reaction  there  might  well  be  criti- 
cism of  the  absence  of  an  unbiased  review  of  the 
safety  of  any  proposed  project  prior  to  initiation 
of  the  study.  This  concern  of  The  Upjohn  Com- 
pany officers  coincided  with  that  of  the  Depart- 
ment of  Corrections  for  the  State  of  Michigan, 
which  has  primary  responsibility  for  the  safety  of 
all  prisoners  as  wards  of  the  State. 

On  March  3,  1964,  Alexander  Z.  Lane,  M.D., 
Edward  L.  Holmes,  M.D.,  Harold  L.  Oster,  M.D., 
Robert  E.  Medlar,  M.D.,  Alan  B.  Varley,  M.D., 
and  Mr.  Ralph  Willy  met  to  discuss  the  im- 
portant responsibility  of  the  Company  and  the 
State  for  the  safety  of  inmate  volunteers  par- 
ticipating in  these  research  projects.  They  recom- 
mended the  formation  of  a  Protocol  Review  Com- 
mittee to  evaluate  all  medical  research  projects  to 
be  conducted  in  the  State  of  Michigan  within  the 
jurisdiction  of  the  Department  of  Correction.^  In 
May,  1964,  the  Commission  approved  the  appoint- 
ment of  an  advisory  Protocol  Review  Committee 
to  assist  the  Department  of  Corrections  by  re- 
viewing research  proposals  to  be  carried  out  on 
volunteers  under  jurisdiction  of  the  Department.* 

In  April,  1964,  Mr.  Gus  Harrison,  Director,  De- 
partment  of  Corrections,   invited  five  physicians. 


One  of  the  ward  rooms  for 
in-patient  volunteers  at  the 
prison  research  station. 


MICHIGAN  MEDICINE    OCTOBER  1969    1025 


924 


PROTOCOL  RESEARCH/Continued 

Edward  A.  Carr,  M.D.,  Joseph  A.  Preston,  M.D., 
Philip  A.  Riley,  Jr.,  M.D.,  Ross  V.  Taylor,  M.D., 
and  Chris  J.  D.  Zarafonetis,  M.D.,  to  become  mem- 
bers of  a  Protocol  Review  Committee.*  All  ac- 
cepted and  Dr.  Taylor  was  appointed  Executive 
Secretary  and  was  asked  to  serve  as  Chairman 
of  the  Committee.  Each  member  had  skills  and 
knowledge  in  specific  areas  which,  it  was  antici- 
pated, would  be  of  importance  to  the  work  of  the 
Committee. 

In  May  1964,  Alan  B.  Varley,  M.D.,  Alexander 
Z.  Lane,  M.D.,  and  Chris  J.  D.  Zarafonetis,  M.D., 
met  with  the  Commission  to  discuss  experiences 
with  the  development  of  new  drugs.  The  Com- 
mission agreed  to  volunteer  participation  by  pri- 
soners in  experiments  involving  new  compounds 
if  the  inmates  were  fully  informed  in  non-scientific 
terms  of  the  nature  of  the  experiment  and  were 
given  permission  to  withdraw  at  any  time.* 

THE  COMMISSION  ALSO  recommended  the 
appointment  of  a  special  advisory  committee  to 
assist  in  determination  of  policies  concerning  hu- 
man researcli.  This  advisory  committee  was  to  con- 
sist of  representatives  of  the  Michigan  Department 
of  Corrections,  Michigan  Department  of  Health, 
and  the  then  existing  two  schook  of  Medicine. 
Ernest  D.  Gardner,  Ph.D.,  Dean  of  the  Wayne 
State  University  College  of  Medicine,  William  N. 
Hubbard,  M.D.,  Dean  of  the  University  of  Michi- 
gan School  of  Medicine  and  Albert  E.  Heustis, 
M.D.,  Director  of  the  Michigan  Department  of 
Health,  agreed  to  serve  on  this  Advisory  Com- 
mittee. Commissioner  Duane  L.  Waters,  M.D.,  was 
appointed  to  represent  the  Commission. 

CONSTITUTION  OF  THE  REVIEW  COMMITTEE: 

The  complete  statement  of  purpose  and  func- 
tions of  the  Protocol  Review  Committee  was  as 
follows: 

I.  PURPOSE:  To  review  and  render  an  opinion 
to  the  Director  of  the  Department  of  Corrections 
on  the  safety  and  suitability  of  research  protocols 
submitted  by  the  Parke,  Davis  or  Upjohn  com- 
panies on  studies  to  be  conducted  in  the  prison 
system  of  the  State  of  Michigan. 

II.  MEMBERS:  The  Committee  will  be  ap- 
pointed by  the  Director  of  the  Department  of 
Corrections,  shall  report  directly  to  him,  and  will 
consist  of  three  to  five  physicians  with  previous 
research  experience,  located  in  the  Michigan  area. 
One  member  of  the  Committee  shall  be  appointed 
Executive  Secretary  and  shall  be  responsible  for 
the  administration  of  Committee  functions. 


•Dr.  Allen  R.  Hennes  was  added  to  the  Ck>mmittee  to 
represent  the  Wayne  State  University  Medical  School. 
Following  Doctor  Hennes'  untimely  death,  Dr. 
Lawrence  H.  Power  was  appointed  to  the  Committee. 
Park  W.  Willis,  M.D.,  joined  the  Committee  to  fill  the 
vacancy  created  when  Dr.  Joseph  Preston  moved  to 
another  state. 


Defibrillator  monitor  in  Southern  Michigan  Pri- 
son room  for  special  studies. 


III.  DUTIES:  The  Committee  shall  meet  once 
monthly  to  review  all  protocols  forwarded  to  the 
Director  of  the  Department  of  Corrections  by  the 
involved  companies.  At  the  discretion  of  the  Exec- 
utive Secretary,  Protocols  representing  repetition 
of  previously  approved  studies,  studies  of  pre- 
viotisly  reviewed  drugs  with  only  minor  protocol 
changes,  diagnostic  procedures,  or  studies  involv- 
ing no  drug  or  commercially  available  drugs  may 
be  reviewed  informally  by  letter.  In  such  instances 
recommendation  for  approval  or  disapproval  may 
be  communicated  to  the  Director  of  the  Depart- 
ment of  Corrections  without  a  formal  Committee 
meeting.  All  protocols  involving  drugs  new  to  the 
prison  system  shall  be  formally  reviewed  by  the 
Committee. 

IV.  STIPENDS:  Stipends  and  expenses  (travel) 
use  of  consultants,  etc.  are  paid  by  the  State  Board 
of  Corrections  from  a  gjeneral  operating  fund  pro- 
vided equally  by  the  Upjohn  and  Parke,  Davis 
companies. 

OPERATIONS   OF  THE   PROTOCOL   REVIEW 
COMMITTEE 

The  general  plan  for  propK>sal  review  and  im- 
plementation of  protocols  is  as  follows: 

a.  The  company  or  individual  wishing  to  initi- 
ate a  research  project  forwards  an  appropriate 
number  of  copies  of  the  profxjsed  protocol  with 
necessary  information  to  the  Director  of  the  De- 
partment of  Corrections. 

b.  One  copy  remains  in  the  Director's  office 
and  copies  are  forwarded  to  the  Executive  Secre- 
tary of  the  Committee  for  distribution  to  Com- 
mittee members. 

c.  The  Committee  reviews  the  protocol  for 
evidence  of  medical  safety  and  suitability;  one  or 
more  representatives  of  the  sp>on soring  company 
are  present  at  meetings  involving  review  of  proto- 
cols submitted  by  that  company  and  provide  any 
additional  information  needed  by  the  Committee 
in  its  consideration  of  the  protocol. 

d.  The  Executive  Secretary  forwards  the  recom- 


1026    MICHIGAN  MEDICINE    OCTOBER  1969 


925 


mendation  of  the  Committee  for  approval  or  dis- 
approval (with  a  brief  explanatory  note)  to  the 
Director  of  the  Department  of  Corrections  as 
promptly  as  p>ossible. 

e.  The  Director  of  the  Department  of  Cor- 
rections, after  review  of  the  Committee's  recom- 
mendations, approves  or  disapproves  the  protocol 
by  letter  to  the  proposer. 

DISCUSSION: 

As  far  as  can  be  ascertained,  this  working  part- 
nership  between   separate   units  of  State  govem- 
j  ment  for  the  advancement  of  human  research  is 
!  unique  to  Michigan.  The  wisdom  of  such  a  part- 
nership is  obvious  if  one  considers  the  responsi- 
bilities of  each   of   the  concerned   agencies.   The 
j  Department  of  Health  must  be  concerned  with  all 
i  aspects  of  public  health,  the  Department  of  Cor- 
;  rections  must  be  entirely  responsible  for  the  im- 
I  prisoned  "wards  of  the  State,"  and  the  Medical 
Schools  must  be  continuously  concerned  with  all 
aspects  of  medical  research  and  education. 

The  first  meeting  of  the  Protocol  Review  Com- 
mittee on  May  22,  1964  was  an  organizational 
one.  Since  June  1,  1964,  the  Committee  has  met 
at  monthly  intervals  to  review  research  protocols 
and  make  recommendations  concerning  them  to 
the  Department  of  Corrections.  Protocols  have 
been  primarily  submitted  by  the  Parke,  Davis 
Company  and  The  Upjohn  Company,  but  also 
by  the  R.  P.  Scherer  Cooporation,  The  University 
of  Michigan  and  the  Henry  Ford  Hospital. 

The  majority  of  the  protocols  have  come  from 
two  Michigan-based  pharmaceutical  companies. 
One  hundred  and  thirty-eight  (138)  protocols 
from  the  Parke,  Davis  Company  and  174  from 
The  Upjohn  Comj>any  were  approved  in  the  first 
five  years. 

The  usual  procedure  has  been  for  the  Com- 
mittee and  representatives  of  each  pharmaceutical 
firm  to  meet  together  as  a  group  for  general  dis- 
cussion. Then  the  Committee  and  representatives 
of  each  company  in  turn  have  a  closed  session 
for  consideration  of  the  protocols  submitted  by 
that  firm.  Protocols  of  one  company  are  not,  of 
course,  discussed  with  representatives  of  other 
companies.  Frequently  the  Committee  has  sug- 
gestions for  modifying  protocols  to  make  them" 
more  safe  for  the  subjects  or  to  improve  the  in- 
formation yield  from  the  study. 

It  should  also  be  noted  that  approval  of  a  pro- 
tocol by  the  Michigan  Protocol  Review  Committee 
does  not  ipso  facto  allow  a  research  project  to  be 
initiated.  Even  after  approval  by  this  committee, 
the  recommendation  and  comments  on  safety  and 
suitability  of  the  proposed  research  are  g^ven  to 
the  Director  of  the  Department  of  Corrections 
and  his  final  approval  is  required  before  the  study 
can  be  initiated. 

PARTICIPATION  BY  the  prisoner?  in  these 
investigations  within  the  prison  is  entirely  volun- 


tary. No  individual  inmate  is  asked  to  participate. 
Advertisements  are  placed  in  the  prison  news- 
paper and  volunteers  are  obtained  exclusively  by 
this  avenue.  Volunteers  must  initiate  their  own 
participation  by  sending  in  a  request  as  explained 
in  the  advertisement.  Inmate  participation  in  such 
research  programs  has  no  influence  in  considera- 
tion for  parole  or  pardon.  Payment  to  volunteers 
has  been  set  at  a  low  level  so  that  it  cannot  be 
viewed  as  a  strong  inducement  to  participation. 
The  attitude  of  the  volunteers,  although  difficult 
to  evaluate,  is  in  general  one  of  making  a  con- 
tribution to  society. 

Since  April  1,  1964,  18,278  men  have  been 
"screened"  as  possible  participants  in  drug  studies. 
If  an  inmate  meets  the  medical  requirements,  he 
is  then  eligible  for  participation  in  studies  at 
either  the  Parke,  Davis  Clinic  or  Upj6hn  Clinic. 

THROUGH  1968  there  were  174  studies  in- 
volving 5,296  subjects  in  the  Upjohn  Clinic. 
(Table  1.)  In  the  year  1967,  as  an  example  of  the 
distribution  of  the  studies,  the  Upjohn  Research 
Clinic  {>erformed  18  Phase  I  studies,  6  Phase  II 
studies,  and  3  Phase  III  studies.  Together  these 
involved  989  subjects  for  a  total  of  29,751  man- 
days. 

The  Parke,  Davis  Clinic  since  March  16,  1964 
has   had   5,641    volunteers  particif>ate  in   studies. 


TABLE   1 

THE   UPJOHN   CO.   RESEARCH  ACTIVITIES 

SOUTHERN   MICHIGAN   STATE   PRISON 


Year 

1964 
1965 
1966 
1967 
1968 

Totals 


No. 

No. 

Studies 

Subjects 

41 

1299 

33 

802 

42 

1216 

27 

989 

31 

990 

174 


5296 


TABLE  2 

PARKE,   DAVIS  &  CO.   RESEARCH  ACTIVITIES 

SOUTHERN   MICHIGAN   STATE   PRISON 


Year 

1964 
1965 
1966 
1967 
1968 


No. 

No. 

Studies 

Subjects 

32 

638 

28 

1629 

24 

1204 

20 

774 

34 

1396 

Totals 


138 


Year 

1964 
1965 
1966 
1967 
1968 


TABLE  3 
ALL  CLINICAL   RESEARCH   ACTIVITIES 
SOUTHERN    MICHIGAN   STATE   PRISON 

No. 
Studies 


Totals 


73 
61 
66 
47 
65 

312 


5641 


No. 
Subjects 

1937 
2431 
2420 
1763 
2386 

10937 


MICHIGAN  MEDICINE    OCTOBER  1969    1027 


926 


PROTOCOL  RESEARCH/Continued 

(Table  2)  lists  the  number  of  studies  and  subjects 
at  the  Parke,  Davis  Research  Clinic  tabulated  by 
year.  There  were  31,907  patient  days  involving 
1,204  subjects  in  1966.  and  22,102  patient  days 
involving  1,396  subjects  in  1968. 

From  (Table  3)  it  can  be  seen  that  10,937  volun- 
teer subjects  have  participated  in  312  protocol 
studies  from  the  inception  of  the  Protocol  Review 
Committee  through  1968. 

SOME  STUDIES  do  not  require  screening  and 
some  volunteers  are  used  in  more  than  one  study. 
Many  volunteers  are  screened  three  or  four  times 
a  year.  The  physical  examinations  done  prior  to 
a  study  are  sometimes  an  added  bonus  to  the 
volunteers  throiigh  the  detection  of  disease  not 
previously  known.  At  any  given  time,  there  are 
about  1,200  inmates  participating  in  the  research 
program. 

Prior  to  the  establishment  of  the  Protocol  Re- 
view Committee,  the  study  of  new  compounds  was 
not  pennitted  at  the  Southern  Michigan  State 
Prison.  However,  since  the  formation  of  the  Com- 
mittee, a  majority  of  the  protocols  have  been  cpn- 
cemed  with  Phase  I  tests.  It  should  be  noted 
further  that  despite  the  large  number  of  Phase  I 
studies  not  a  single  serious  adverse  drug  reaction 
has  been  encountered  among  the  test  subjects. 

SUMMARY 

Whenever  prison  inmates  serve  as  volunteer 
subjects  in  research,  safeguards  against  coercion 
and  careful  consideration  of  the  safety  of  the 
studies  are  particularly  necessary.  As  wards  of  the 
State,  prisoners  are  entitled  to  the  protection  af- 
forded by  the  existence  of  a  reviewing  body  com- 
prised  of  scientifically  qualified   individuals. 

The  Michigan  Protocol  Review  Committee  is 
offered  as  an  example  of  such  a  reviewing  body. 
The  f>olicies  and  operations  of  such  a  reviewing 
body  should  be  established  and  monitored  by  an 
advisory  group  of  representatives  of  the  concerned 
governmental  and  scientific  agencies.  This  insures 
the  qualifications  of  the  members  of  the  reviewing 
committee  and  protects  against  possible  coercive 
practices  in  the  selection  of  subjects.  The  advisory 
group  in  Michigan  has  included  representatives 
of  the  State  Department  of  Correction,  State  De- 
p>artment  of  Health,  and  two  of  the  schools  of 
medicine. 

There  are  alternative  arrangements  to  insure 
that  those  conducting  research  among  prison  vol- 
unteers are  held  to  careful  public  accountability. 


One  alternative  is  exemplified  by  the  New  York 
State  proposal  to  which  reference  was  made  at  the 
outset  of  this  article.  The  arrangement  has  as  one 
of  its  important  features  the  establishment  of  an 
entirely  new  group  not  composed  of  experienced 
scientific  investigators  and  not  deriving  its  au- 
thority from  agencies  or  institutions  already  exist- 
ing in  the  state. 

The  successful  operation  of  a  Protocol  Review 
Committee  in  the  State  of  Michigan,  under  poli- 
cies established  by  an  advisory  g^oup  of  repre- 
sentatives of  established  state  agencies  and  medical 
schools  suggests  that  the  mechanisms  such  as  out- 
lined in  the  New  York  proposal,  are  unnecessary. 
Without  additional  legislative  action  most  states 
could  probably  establish  research  review  commit- 
tees similar  to  Michigan's  under  authority  already 
implied  in  their  existing  legal  structures. 

That  the  formula  devised  in  Michigan  is  success- 
ful  is  attested  by  the  fact  that  in  an  experience 
of  over  five  years  duration  and  in  several  hundred 
research  studies  frequently  involving  new  drugs 
administered  to  humans  for  the  first  time,  no 
serious  adverse  reactions  have  occurred.  As  far 
as  can  be  ascertained  the  State  of  Michigan  was 
the  first  to  recognize  its  responsibilities  and  estab- 
lish an  adequate  mechanism  which  protects  the 
participating  volunteers  and  yet  permits  the 
properly  directed  and  necessary  continuing  human 
clinical  research. 

REFERENCES 

1.  State  of  New  York  Senate  —  Assembly  February 
20,   1968        S.4015-A  A.5586-A 

An  Act:   To  amend  the  public  health  law,  in  re- 
lation to  human  research. 

2.  Minutes  of  meeting  of  the  State  of  Michigan  Cor- 
rections Commission,  November  1-2,  1961. 

3.  Minutes  of  meeting  of  the  State  of  Michigan  Cor- 
rections Commission,  December  6-7,  1961. 

4.  Minutes  of  meeting  of  the  Sute  of  Michigan  Cor- 
rections Commission,  May  2-3,  1962. 

5.  Minutes  of  meeting  of  the  Sute  of  Michigan  Cor- 
rections Commission,  May  2-3,  1962. 

6.  Minutes  of  meeting  of  the  Sute  of  Michigan  Cor- 
rections Commission,  August  1-2,  1962. 

7.  Minutes  of  meeting  of  the  Sute  of  Michigan  Cor- 
rections Commission,  March  6-7,  1963. 

8.  Holmes,  E.  L.:  Personal  correspondence,  1968. 

9.  Minutes  of  meeting  of  the  Sute  of  Michigan  Cor- 
rections Commission,  May  6-7,  1964. 

10.    Minutes  of  meeting  of  the  State  of  Michigan  Cor- 
rections Commission,  June  17-18,  1964. 


1028    MICHIGAN  MEDICINE    OCTOBER  1969 


927 


^^nat0  Conritrr? nt  Witsoitxtion  ^o.  340 

Offered  by  Senators  Stamm,  Zollar,  DeMaso  &  Fleming 

A  CONCURRENT  RESOLUTION  RELATIVE  TO  THE  ESTABLISHMENT  OF  AN 

OUTSIDE  MEDICAL  AND  PHARMACEAUTICAL  TEST  FACILITY  AT  THE  STATE 

PRISON  OF  SOUTHERN  MICHIGAN. 

WHEREAS,  The  Upjohn  Company,  a  Michigan  pharmaceutical  firm,  constructed  a  medical 
and  pharmaceutical  testing  facility  inside  the  walls  of  the  State  Prison  of  Southern  Michigan  in 
1963;  and 

WHEREAS,  The  entire  cost  of  construction  and  operation  of  the  faciUty  was  and  is  borne 
by  the  Upjohn  Company;  and 

WHEREAS,  The  testing  procedures  used  in  the  facility  are  imder  careful  supervision  of  a 
panel  of  medical  experts,  whose  advise  to  the  Department  of  Corrections  hais  resulted  in  cau- 
tious experimentation  without  mishap;  and 

WHEREAS,  The  inmates  who  have  volunteered  for  participation  in  such  experiments  have 
been  properly  remunerated;  and 

WHEREAS,  The  operation  of  the  facility  has  proven  to  be  of  great  benefit  to  the  State  of 
Michigan  and  provided  valuable  pharmaceutical  and  medical  knowledge;  and 

WHEREAS,  The  Upjohn  Company  now  requests  that  permission  be  granted  for  construction 
of  a  similar  facility  in  the  Trusty  Division  of  die  State  Prison  of  Southern  Michigan,  under  the 
same  conditions  as  the  existing  facility;  and 

WHEREAS,  The  Upjohn  Company  has  offered  to  include  in  the  proposed  Trusty  Division 
facUity  provisions  for  a  needed  dispensary  to  be  placed  at  the  service  of  the  prison;  now  therefore 
belt 

RESOLVED,  That  the  legislature  hereby  authorizes  the  Department  of  Corrections  to  permit 
the  Upjohn  Company  to  construct  and  operate  a  medical  and  Pharmaceutical  Testing  Facility 
in  the  Trusty  Division  of  the  State  Prison  of  Southern  Michigan  with  the  understanding  that 
the  building  will  include  provisions  for  a  dispensary  to  be  placed  at  the  service  of  the  prison, 
and  that  the  Upjohn  Company  will  pay  the  full  cost  of  construction  and  c^raticm  of  the  facility, 
and  that  operating  poUcies  will  be  the  same  as  those  of  the  inside  facility,  and  be  it  further 

RESOLVED,  That  a  copy  of  this  resolution  be  transmitted  to  the  Department  of  Onrections 
for  forwarding  to  the  Upjolm  Company. 


Si 


Htm. 


i?^i 


<^e./y/*y.  y[4>^#^^. 


Beontaiy  of  lk«  8«Hate. 


928 


RELEASE  I 

Know  all  men  by  these  presents  that  I  have  voluntarily  released  and  forever  discharged  and  do  hereby  release 
and  forever  discharge  Parke,  Davis  &  Company,  the  Department  of  Corrections  of  the  State  of  Michigan,  and  the  agents,  servants 
and  employees  of  each  of  them  of  and  from  any  and  all  claims  of  whatsoever  name  or  nature,  past,  present  or  future,  in  connection 
with  or  growing  out  of  my  receiving 


or  the  withdrawal  of  blood  or  other  fluids  from  my  body  whether  such  claims  be  by  reason  of  illness  or  damage  caused  by  the 
administration  of  said  drug,  the  withdrawal  of  blood  or  fluids  or  otherwise. 

I  further  state  that  I  recognize  that  I  may  be  receiving  a  drug  which  has  not  been  generally  approved  for  human 
use  or  for  human  use  in  the  dosage  or  form  which  I'  am  receiving  and  that  I  am  taking  such  drug  and  permitting  withdrawal  of 
blood  and  fluids  voluntarily  without  any  assurances  whatsoever  having  been  made  to  me. 


Dated: . ^ .„^.^  .  197 

Witness: ......— .......«......^......»^w~^....... 


COMPENSATBQ^.. 


FORM  SeO  PRINTED   IN   ^.t.A.  (FEB.  70» 


929 


•  Vsr'^-/*'^^^"*^  ^^^^Z^i^t^t^iJ^H^    ^  ^"'^'^i^ 


Outline  of  Procedures,  Purposes  and  Risks  Involved  for  Parke-Davis  Protocol 

Cm  I  ri  I  I  "  II  1 1  I"  Ml"  *'i« 
ill *   >M h/ . ,.  

The  purpose  of  this  trial  is  to  study  the  tolerance  of  this 
compound  in  normal  volunteers. 

This  drug  has  been  found  to  t  "  i ■■-■       ^-   ••  --  --^ -^  ^^  ^•^^■■^ 

blood  when  given  for  several  weeks,  to  laboratory  animals.   It  may,  therefore, 
eventually  be  helpful  in  treating  diseases  where  these  -^i-,-'-  7  substances  are 
deposited  in  the  lining  of  the  blood  vessels  in  greater  than  normal  amounts ,  O 

je<"  '■'■•      -■_;;   _"!^- ■     '"  "*  _^  J._'.,'ll_  '"   '  '■   -'     '     '"•  '  ''''^^*^'^'^     It  is  also 

important,  from  your  point  of  view,  to  know  that  this  drug  has  been  given  in 
high  doses  for  several  months  to  various  species  of  animals,  without  any  ill 
effects  as  a  result.   Furthermore,  two  other  groups  of  men  at  Jackson  have 
already  received  the  drug,  in  single  doses  every  other  weeK^""'"'  .% 

and  showed  no  unfavorable  effects.  ^**** 

For  these  reasons,  we  do  not  expect  that  you  will  have  any  serious  reac- 
tions to  the  drug.   Still,  this  is  an  experimental  drug  which  has  had  limited 
testing  in  people.   It  is,  therefore,  important  that  you  do  not  volunteer  for 
this  study  if  you  have  any  disease  of  the  liver,  kidneys  or  other  organs,  since 
it  could  affect  the  way  your  body  handles  the  drug.   We  also  do  not  want  you  to 
volunteer  if  you  have  had  any  bad  reactions  to  drugs  in  the  past.   You  will  be 
thoroughly  checked  by  the  doctor  and  by  the  laboratory  analysis  of  blood  and 
ui^ine  specimens  to  make  certain  that  you  have  none  of  these  problems  now,  and 
will  be  similarly  rechecked  after  you  have  received  the  medication. 

During  the  trial,  we  want  you  to  be  candid  in  telling  us  of  any  symptoms 
you  experience,  whether  or  not  you  think  they  may  be  rels^ted  to  the  drug.   This 
is  a  double  blind  trial,  which  means  that  some  of  you  will  receive  blanks 
(placebos)  and  some  active  medication,  with  neither  you  nor  our  staff  knowing 
who  is  receiving  which  preparation.   You  will  receive  the  medication  each  morn:^ 
ing  for  one  week.   The  doses  of  active  medication  ar^J  ^'      ' '. ..  ^ ''^  daily. 

It  is  also  understood  that  you  are  not  to  take  any  other  medication  oif^to 
give  blood  during  the  time  specified  as  related  to  this  study. 

An  opportunity  is  given  you  now  to  ask  furtl^er  questions  about  the  details 
and  the  procedures < 

I  have  read  the  above,  understand  the  nature  of  the  study  and  agree  to  pro- 
ceed as  outlined  and  to  adhere  to  the  regulations  of  the  institution  and  the   , 
clinic  throughout  the  period  of  the  study.  ^     . 

1 

DATED: 

SIGNED:  _ 


WITNESSED: 


930 


New  laboratories  of  Upfohn  and  Parke-Davis  stand  between  prison  hospital  and 
Cell  Block  9  at  State  Prison  of  Southern  Michigan,  in  Jackson,  Mich. 

RESEARCH 

Drug  tests  behind  bars 

Upjohn  and  Parke-Davis  have  broken  precedent  in  building 
their  own  labs  in  huge  Jackson  (Mich.)  prison,  where  they  can 
run  better  clinical  tests  than  ever  before  on  new  drugs 


If  you  wanted  to  test  a  new  drug  on 
hundreds  of  human  volunteers  who 
have  much  the  same  sort  of  hfe  and 
who  can  be  continuously  supervised 
for  months  or  years,  \yhat  better 
place  to  look  than  in  a  prison? 

For  many  years,  drug  companies 
and  the  National  Institutes  of  Health 
have  had  cooperative  agreements 
with  penal  institutions  all  over  the 
country,  permitting  them  to  run  clin- 
ical tests  on  inmates.  But  they  have 
generally  been  barred  from  instal- 
ling labs  at  the  institutions. 

Now,  Upjohn  Co.  and  Parke,  Davis 
6f  Co.  have  broken  into  prison  in  a 
big  way,  with  half  a  million  dollars' 
worth  of  lab  facilities  (pictures)  at 
the  State  Prison  of  Soutnem  Mich- 
igan. This  prison,  at  Jackson,  is  rated 
as  the  world's  largest  walled  peni- 
tentiary, enclosing  57  acres  and  4,141 
prisoners. 

The  two  companies'  laboratories, 
adjacent  to  the  prison  hospital,  are 
said  to  be  the  first  such  facilities 
ever  built  by  drug  companies  inside 
U.  S.  prison  walls.  They  were  com- 
pletea  this  spring  at  a  cost  of  $266,- 
000  for  Upjohn's  labor  and  $226,000 
for  Parke-Davis,  and  title  was  then 
turned  over  to  the  state. 

Research  dream.  Fron)  the  outside, 
the  two  buildings,  connected  by  a 
covered  walk,  aren't  too  impressive. 
Yet  research  people  in  both  com- 


/ 


V:; 


Prisoner's  mouth  is  checked  to  be  sure  he 


One  inmate  technician  watches  another  counting  bkxxi  cells.  Inmates  learn  lab 
techniques;  this  givi?s  them  chance  to  gain  skills  useful  in  outsi'de  world. 


SS      RESEAACH 


BUSINESS  WEEK  Juiw  27, 1964 


931 


IT-^ 


F-'S  '•    ^N   - 


'«., 


Gus  Harrison,  Michigan's  director  of  corrections,  pressed  the  lab  idea 


panics  say  the  setup  is  a  dream  come 
true.  It  will  permit,  for  the  first  time, 
what  they  call  optimum  control  test- 
ing of  new  drugs. 

The  companies  expect  testing  at 
Jackson  to  permit  unsuitable  drugs 
to  be  detected  and  discarded  in  as 
little  as  one  month,  compared  with  a 
standard  three  to  five  years  for  con- 
ventional clinical  testing.  They  also 
expect  far  more  accurate  findings  on 
how  drugs  affect  cells  and  enzymes. 
The  groundwork  for  a  cure  for  the 
common  cold  or  for  cancer  might 
well  be  laid  at  Jackson. 

Drugs  these  days  are  accomplish- 
ing remarkable  results  partly  be- 
cause they  are  so  much  more  power- 
ful and  so  specifically  formulated  for 
their  tasks.  But  as  their  potency  in- 
creases, so  does  their  inherent  risk. 
Thus,  accurate  testing  on  human 
volunteers  is  ever  more  vital. 

Personnel  problem.  It  is  also  in- 
creasingly difficult  to  find  enough 
volunteers — or  even  enough  clinical 
investigators  to  test  all  the  new  drugs 
coming  out  of  the  laboratory. 

With  the  spread  of  medical  in- 
surance, charity  wards  in  hospitals 
are  disappearing.  These  were  tradi- 
tionally an  area  for  studies  of  new 
drugs  as  well  as  for  the  teaching 
of  medical  students.  Drug  tests  can 
still  be  run  much  more  cheaply  in 
foreign  countries,  but  companies  ad- 
mit a  risk  of  inadequate  controls 
and  of  a  political  backfire. 

Through  doctors  who  are  compe- 
tent clinical  investigators,  tests  can 
also  be  run  on  patients  all  over  the 
country,  though  it's  a  slower  proc- 
ess than  with  mass  volunteers  and 
requires  more  contact  work.  There 
is  a  severe  shortage  of  top  research- 
ers for  routine  testing  jobs. 

"There  are  a  lot  of  doctors  who 
are  superb  doctors,"  says  Dr.  Har- 


old L.  Upjohn,  Upjohn's  director  of 
clinical  research.  "But  they  do  not 
have  the  time,  the  knowledge  (al- 
though they  do  not  know  it),  or  the 
patients  to  test  drugs  adequately." 

Yet  the  drug  companies  must  re- 
spond to  the  strict  1963  amend- 
ments to  the  Food,  Drug  &  Cos- 
metics Act  that  empower  the  Food 
&  Drug  Administration  to  require 
a  fuller  accounting  on  all  drug  test- 
ing. 

Finding  an  answer.  Many  a  clini- 
cal test  of  a  new  drug  turns  up  an 
aberrant  finding  that  leaves  the  drug 
researchers  uneasy  even  after  the 
dnig  has  been  licensed.  It  might  be 
a  freakish  reaction  to  a  compound, 
a  genuine  effect  of  the  drug,  or  a 
technician's  sloppiness. 

"We  can  never  erase  doubt  in  our 
own  minds,"  a  technician  says.  The 
prison  labs  are  a  step  toward  elimi- 
nating such  doubts. 

At  Jackson,  with  laboratory  fa- 
cilities now  available  for  substantial 
expansion  of  the  testing  program, 
Upjohn  and  Parke-Davis  are  tap- 
ping a  rich  source  of  volunteers  for 
round-the-clock  experiments  under 
round-the-clock  supervision.  Pris- 
oners are  volunteering  by  the 
hundreds  for  testing  purposes. 

Willing  help.  Many  want  the 
money,  which  ranges  from  a  few 
cents  to  as  much  as  $15  a  day  on  a 
scale  set  by  the  prison  board.  Some 
are  saving  up  for  their  parole  period 
when  a  small  bankroll  can  mean  the 
difference,  as  it  did  for  one  prisoner 
recently,  between  getting  out  or  be- 
ing kept  in  prison  for  lack  of  a  job 
or  friends  outside.  Some  send  money 
to  their  families,  too. 

Prisoners  also  get  a  valuable  feel- 
ing of  self-respect.  For  some,  it  is  the 
first  time  they  have  ever  done  any- 
thing to  benefit  society;  some  even 

BUSINESS  WEEK  June  27. 1964 


932 


leam  the  trade  of  lab  technician, 
with  a  chance  to  find  an  honest  job 
in  a  hospital  later. 

"I'm  helping  other  people,"  says 
one  inmate  technician,  "and  I've 
never  felt  hke  this  in  my  hfe." 

Selling  the  idea.  Testing  of  drugs 
in  U.  S.  prisons  dates  back  to  1906, 
when  Pri-s.  Theodore  Roosevelt 
pressed  for  the  first  food  and  drug 
controls.  It  increased  during  World 
War  II.  Parke-Davis  has  been  testing 
at  Jackson  prison  for  30  years,  Up- 
john for  eight. 

Three  years  ago.  Dr.  Harold  Up- 
john broached  the  idea  of  company 
laboratories  at  the  prison  to  Gus 
Harrison,  director  of  the  Michigan 
Board  of  Corrections.  He  and  Har- 
rison took  the  idea  to  the  Prison 
Commission  with  the  argument  that 
research  labs  could  be  considered  an 
extension  of  prison  work  shops  and 
other  activities  geared  to  rehabilita- 
tion of  prisoners. 

The  commission  approved,  and  the 
state  issued  invitations  to  other 
Michigan  drug  companies  to  par- 
ticipate in  the  project.  Parke-Davis 
accepted. 

How  it  works.  Under  their  agree- 
ment with  the  prison  board,  the 
companies  are  training  inmates  to 
run  the  tests  that  can  be  handled  in 
the  prison  labs.  Other  tests  are  com- 
pleted in  their  respective  headquar- 
ters facilities,  Parxe-Davis  in  Ann 
Arbor  and  Upjohn  at  Kalamazoo. 

The  Board  of  Corrections  decides 
which  drugs  may  be  tested  at  the 
prison.  Each  case  is  reviewed  by  a 
board  of  five  doctors  and  a  blue-rib- 
bon committee  that  includes  the 
deans  of  the  state's  medical  schools. 
Right  now,  the  two  companies  are 
testing  a  broad  range  or  drugs  at 
Jackson,  including  anti-coagulants, 
analgesics,  anesthetics,  steroids, 
tranquilizers,  and  deodorants. 

With  their  new  ability  to  keep 
close  laboratory  controls  on  tests 
with  prisoners,  Parke-Davis  and  Up- 
john expect  soon  to  start  testing 
drugs  that  have  never  been  tried  on 
human  subjects.  Tests  at  the  prison 
are  designed  primarily  to  measure 
the  toxicity  of  a  drug,  rather  than  its 
eflBcacy. 

Initial  doses  are  as  low  as 
1/lOOOth  of  LD  50  (the  lethal  dose 
for  50  out  of  100  laboratory  ani- 
mals, adjusted  to  man's  weight). 
They  are  then  built  up  gradually 
to  the  point  where  adverse  reactions 
appear. 

Much  faster.  At  Jackson,  a  large 
number  of  persons  can  be  run 
quickly  through  the  early  stages  of 
toxicity  testing,  revealing  the  specific 
reactions  that  must  be  explored.  In 
the  past,  much  of  a  researcher's 
time  in  checking  on  the  toxicity  of 


mm 


Each  volunteer  gets  a  physical,  and 
about  half  are  eliminated  from  testing. 

a  new  drug  had  to  be  spent  in 
running  around  the  country,  coordi- 
nating clinical  investigators. 

"We're  willing  to  stick  our  necks 
out  on  an  unsuitable  drug  in  a 
month  now,"  says  a  Parke-Davis  re- 
searcher. The  Jackson  project  is 
hailed  by  Dr. '  P.  F.  R.  de  Caires, 
Parke-Davis  director  of  clinical  in- 
vestigation, as  a  great  aid  to  speed 
and  accuracy  in  pinning  down  the 
areas  for  further  study. 

Since  the  lab  opened,  Parke-Davis 
has  already  eliminated  two  new 
chemicals  designed  to  reduce  blood 
cholesterol  level. 

Deeper,  too.  Dr.  Upjohn  is  particu- 
larly interested  in  depth  stuoies  of  a 
drug's  reaction  on  a  given  prisoner, 
revealing  basic  facts  about  drugs 
generally.  Upjohn  is  stressing  two 
10-bed  metabolic  wards  at  its  lab  for 
near-absolute  control  in  drug  studies 
that  may  last  three  or  four  days  or 
several  months  at  a  time. 

These  studies  will  attempt  to  chart 
blood  level,  absorption  ana  excretion 
of  drugs,  as  well  as  toxicity,  in  se- 
lected healthy  men.  This  is  the  ele- 
ment that  is  missing  in  many  drug 
tests  elsewhere. 

"How  can  you  tell  when  you  test 
whole  wards  of  little  old  ladies  with 
broken  hips  if  their  reaction  to  a 
drug  will  be  the  same  as  that  of  a 
17-year-old  girl?"  asks  Dr.  Alan  Var- 
ley,  manager  of  clinical  research  for 
Upjohn. 

With  prisoners,  researchers  can 
precisely  set  the  odds  in  drug  tests. 
"You  can  devote  your  entire  atten- 
tion to  safety,"  says  Varley,  "and 
leam  considerably  more  about  a 
drug." 

In  the  outside  world,  test  subjects 
balk  drug  researchers  at  every  turn, 
albeit  unintentionally.  "People  are 
not  reliable  when  they  are  asked  to 
take  medipine,"  Dr.  Upjohn  says.  In 
a  prison  setup,  they  can  be  checked 
to  be  sure  they  have  followed  in- 
structions precisely.  End 


BUSINESS  WEEK  JuiM  27, 1*M 


933 


JACKSON,  MICHIGAN 

RESEARCH  CLINIC  PAY  SCALE 
(Revised  Copy  2/1/73) 


ROUTINE  SAMPLING  PROCEDURES; 

Blood  samples  (In  and  outpatient  basis:   paid  on  an 
individual  basis,  per  individual  drawing: 

Finger  stick  (Hemolet) 
1-20   cc. 

21  -  100  cc. 
101  -  200  cc. 
201  -  300  cc. 
301  -  500  cc. 

Urine  samples; 

Outpatient  basis: 
Morning  sample 
24-hour  collection 

Inpatient  basis: 

Any  amount,  up  to  and  including  24-hour  collection 

Fecal  samples; 

Outpatient  basis: 

Bowel  movement   aliquot 
24-hour  collection 

Inpatient  basis: 

Paid  for  each  bowel  movement  collected 


$0.25 
1.00 
2.00 
3.00 
4.00 
6.00 


0.25 
1.00 

0.25 


0.25 
1.00 


0.25/8tool 


MEDICATION  (In  and  outpatient  basis); 

Topical  medication 

Oral  medication 

Injections  (I.V.,  I.M.,  or  I.D.) 

Epidural  anesthetic  iniection 

When  drug  is  being  administered  for  the  first  time 
in  humans i 

Oral  medication 

Injections  (I.V.,  I.M. ,  or  I.D.) 


0.25  ea.  time 
0.25  ea.  time 
1.00/inject. 
2.00/inject. 


0.50  ea.  time 
2.00/inject. 


MISCELLANEOUS  CLINIC  PROCEDURES; 

Fasting  (nothing  to  eat  or  drink,  except  water)  from 

9:00  p.m.  until  the  following  morning's  clinic  procedure 

is  completed  1.00 

Call  to  clinic  for  observation  0.25 

Blood  pressure,  pulse  and/or  temperature:  \ 

Called  to  clinic  on  outpatient  basis  \      J        0.25/recording 

Checked  into  clinic: 

-  series  repeated  up  to  and  including  4  times  a  day       0.25/day 

-  series  involving  more  than  4  times  a  day  and  not 

more  than  8  -  add  0.25/day 


93-999  O  -  73  -  pt.  3  —  10 


934 


"  2  ' 


MISCELLANEOUS  CLINIC  PROCEDURES  (continued): 

Physical  examination: 

Routine  -  blood  pressure,  pulse,  heartbeat 
Detailed  -  blood  pressure,  pulse,  heart,  respiration, 
EENT  &  T,  rectal,  genitals  and  neurological 

Psychiatric  interview: 

If  on  call  for  other  clinic  work  or  inpatient 
Outpatient  (sole  reason  for  being  called  to  clinic) 

Interviews,  completing  questionnaires,  sorting  IBM 

cards,  etc.: 

Outpatient 

Inpatient 
Lengthy  tests,  such  as  MMPI 
Psychological  written  tests 

Special  diet  (any  diet  restrictive  in  nature) 
Checked  into  clinic 
Detailed  to  clinic  for  12  hours  or  more  a  day 

Subjects  having  active  hay  fever  disease  abstaining 
from  taking  medication  to  relieve  the  hay  fever 
symptoms 

Nasal  pressure  measurement  ■ 


0.25 
1.00 


0.50 
0.75 


0.25/te8t 

0.25/d.forra 

1.00 

1.00 

1.00/day 

1.00/day 

1.00/day 


1.00/day 
0.25/measurement 


SPECIAL  CLINIC  PROCEDURES: 

EKG,  EEC  or  BMR  (on  call)  1.00 
X-ray  pictures 

-  for  a  single  film  1.00 

-  for  a  series  of  2  or  more  films  2.00 
Endotrachial  tube  placement  2.50 
Nasal  tube  placement  2.50 
Sigmoidoscopic  examination  2.00 
Intravenous  injections,  par  hour  1.00 
Skin  testing  (series  of  30)  7.50 
Monitoring  rectal  temperature  0.50 
Nasal  swab'  (in  or  outpatient  basis)  0.25 
Deep  finger  cut  for  arterial  blood  0,50 

Gastric  sampling  procedure: 

Placement  of  gastric  tube  and  for  first  hour  of 

sampling  5.00 

Each  additonal  hour  of  sampling  1,00/hour 

Each  "retubing"  as  required  by  study » design  1.00 

Return  of  gastric  sample  as  required  by  study  design  0.25 
Collection  of  saliva  over  entire  gastric  sampling  period    1,00 

Withdrawal  of  blood  cells  or  plasma: 

Withdrawal  of  blood  -  paid  for  on  a  volume  basis  \ 

Relnjection  of  blood  cells  or  plasma 

-  100  cc.  or  less  1.00 

-  more  than  100  cc.  2.00 
•  If  medication  or  isotopes  are  added  before  reln- 
jection .1,00 


935 


3  - 


DIAGNOSTIC  PROCEDURES; 

B.S.P.       Dye  injections 
Post -dye  sample 


1.00 
1.00 
2.00 


P.S.P.   '    Dye  injection 

($0.25)  for  post-dye  injection  sample  (usually  2) 
($0.25)  for  each  force  fluid  (usually  3) 


1.00 
0.50 
0.75 
2.25 


I.V.P.       Fasting 

Enema  (sufficient  to  make  examination) 
Dye  injections 
Necessary  X-rays 


1.00 
1.00 
1.00 
2.00 
5.00 


Xylose 

absorption  test 
Fasting 

Xylose  ingestion 
Blood  sample 
Collection  of  urine 

for 

5 

Barium 

enema 

Fasting 

Enema 

X-ray 

• 

hours 


1.00 
0.25 
1.00 
0.25 
2.50 


1.00 
1.00 
1.00 
3.00 


Upper  or  lower  G.I.  series 
Fasting 

Barium  ingestion 
X-ray 


1.00 
1.00 
1.00 
3.00 


Creatinine  clearance 
Fasting 

Primary  blood  sample 
.  8-hour  blood  sample 

24-hour  urine  (outpatient) 


1.00 
1.00 
1.00 
1.00 
A. 00 


Glucose  tolerance 

Fasting 

Glucose  ingestion 
•-  blood  samples  paid  for  6n  a  volume  basis, 
per  sample 


Expired  air 


Five  (5)  minute  hook-up  or  less  per  time 


1.00 
0.25 


936 


-  4 


DIAGNOSTIC   PROCEDURES    (corttlnued) :  '  ^  j 

Pulmonary  function 

Slit  lamp  eye  examination  (staining,  dilation  and  post-stained 

obser'fration) 
Scraping  of  skin  for  "skin  window" 
Water- loading 

-  250  -  500  cc.  every  hour  for  8  hours  (per  force  fluid) 
Holding  hand  in  ice  water  (2  minutes) 

Virus  inoculations  (nasal  spray  or  swab) 

Monitoring  physiological  function(s)  by  an  electronic  recording  unit: 

-  first  hour  of  recording  and  attachment  of  electrodes 

-  each  additional  hour  (or  fraction  thereof)  of  monitoring 
Psychomotor  testing: 

-  first  hour  of  performance,  monitoring  and  "hook-up" 

-  each  additional  hour  (or  fraction  thereof)  of  psychomotor 

performance 

-  physiological  monitoring 

(Note;   The  foregoing  pay  scale  is  for  a  24-hour  period.) 
Ultraviolet  exposure  (paid  for  each  distinct  area  exposed) 
Audiometric  testing: 

-  first  hour  of  testing  .    , 

-  each  additional  hour 

Exposure  to  ultrasonic  physical  therapy  device 

Slit  lamp  ophthaimo logical  examination 

Intraocular  pressure 

Visual  acuity  test 

Sputum  sample  (single  a.m.  sample,  outpatient) 

Gargle  sample  (gargle  -  saline--return  to  container  -  outpatient) 

Induced  pain  by  Smith  &  Beechler  tourniquet  method 


0.50 

0.75 
0.25 

0.25 
2.00 
1.00 

1. 00 
0.25/hour 

1.00 

0.50/hour 
0.25/hour 

0,75/exposure 

1.00       . 
0.25/hour 
1.00 /exposure  u] 
to  30  min. 
0.75 
0.50 
0.25 

0.25/sample 
0.25/sample 
7.50 


SPECIAL  SAMPLING  PROCEDURES: 

Bone  marrow  aspiration  (hip  or  sternum)  12.00 

Synovial  fluid  withdrawal  12.00 

Arterial  cannula  implacement  and  maintenance  2.00 

-  all  samples  withdrawn  are  paid  for  on  a  volume  basis,  per 

sample 
Intravenous  catheter  implacement  and  maintenance  2.00 

-  all  samples  withdrawn  are  paid  for  on  a  volume  basis,  per 

sample  , 

Nasal  samples  collection  (tissues)  for  24  hours  1.00 

Nasal  wash  (in  or  outpatient  b,asis)  0.25 

Spinal  tap  procedure,  implacement  and  maintenance,  for  purpose 

of  removal  of  spinal  fluid  12.00 

(included  the  first  sample  withdrawn) 

•  for  each  additional  sample  (2-5  cc.)  ^     1.00 


937 


-  5  - 

MINIMUM  PAY; 

The  new  procedure  provides  a  minimum  payment  of  fifty  cents  (50<^)  a  day, 
for  the  duration  of  a  study  28  days  or  longer  in  duration.   The  minimum 
pay  sha^l  be  the  total  payment  for  the  ".medication  phase"  of  the  study, 
when  the  remuneration,  based  on  the  "old  pay  scale"  would  be  less  than 
Fourteen  Dollars  ($14.00).   The  28-day  period  (or  longer)  does  not  include 
the  time  necessary  for  recruiting  or  screening  the  potential  subject,  and 
payment  for  this  preliminary  work  will  be  made  separately  and  apart  from 
the  minimum  pay.   Should,  during  the  course  of  the  study,  additional  proce- 
dures be  required  that  would  cause  the  total  payment  to  be  greater  than 
minimum,  then  the  greater  amount  shall  be  paid. 

FEMALE  SUBJECT  PAY  SCALE;  ,         ' 

Pay  scale  for  females  is  Identical  to  that  of  male  volunteers  as 
stipulated  in  the  previous  pages. 

Certain  female-related  procedures  and  the  pay  rate  is  as  follows: 

Pelvic  examination  (including  samples  for  culture (s)  and/or 

Papanicolauou  smear  1.00 

Midstream  urine  collection 

-  preparation  (cleansing  and  midstream  catch)  .  0.25 

-  urine  sample  0.25 

.       .  0.50 

Endometrial  biopsy  ^     .  12.00 


938 


UNIVERSITY  OF  MONTANA  FOUNDATION 

DEER  LODGE  RESEARCH  UNIT 

DL-07-72 

(Ro  20-5662) 

VOLUNTEER     CONSENT     FORM 

Date: 

I  hereby  volunteer  to  participate  in  this  drug  testing  study  and 
also  to  submit  myself  for  medication  promptly  as  scheduled.  I  have 
been  advised  that  the  medication  is  being  used  for  investigational 
purposes  and  is  new  and  unproven. 

I  understand  that  the  drug  is  being  tested  for  the  first  time  in 
humans  and  that  it  may  eventually  be  used  to  help  treat  certain  types 
of  infections,  particularly  kidney  infections.  However,  I  understand 
that  there  are  no  expected  benefits  to  my  health  from  taking  this  new 
medicine.  I  also  understand  that  I  will  receive  only  one  dose  of  the 
drug,  or  perhaps  only  a  sugar  capsule,  but  I  will  be  unable  to  tell  the 
difference  by  looking  at  the  medicine. 

This  test  will  require  my  spending  24  hours  at  the  research  unit 
and  the  taking  of  three  blood  samples. 

I  further  understand  that  the  main  purpose  of  this  project  is  to 
determine  how  well  the  drug  is  tolerated  by  people  and  also  to  deter- 
mine if  the  drug  produces  any  unwanted  or  undesirable  effects. 

As  with  all  medicines,  I  know  there  is  a  slight  chance  that  I  may 
develop  a  serious  drug  reaction. 


939 


Deer  Lodge  Research  Unit 
Volunteer  Consent  Form 
DL-07-72,  Cont. 


Finally,  if  I  so  desire,  I  may  discontinue  my  activities  in  this 
drug  study  before  it  is  completed. 


I  have  read  all  the  information  above  and  it  has  been  read  aloud 
to  me  by  Dr.  James  D.  Moore.  I  was  given  an  opportunity  to  ask  ques- 
tions and  I  fully  understand  and  agree  to  the  contents  of  this  form. 


Sign  here  above  line 


Right  Thumb  Print 


M.S. P.  Number 


940 

UNIVERSITY  OF  MONTANA  FOUNDATION 

DEER  LODGE  RESEARCH  UNIT 

DL-09-72 

Ro  6-2580  (Sulfamethoxazole/Trimethoprim) 

VOLUNTEER     CONSENT     FORM 


Date: 


I  hereby  volunteer  to  participate  in  this  drug  testing  study  and 
also  to  submit  myself  for  medication  promptly  as  scheduled.  I  have 
been  advised  that  the  medication  is  being  used  for  investigational 
purposes  and  is  new  and  unproven  in  this  country. 

I  understand  that  the  drug  is  in  the  experimental  stage  of  human 
testing  and  that  it  is  a  combination  of  two  drugs  (sulfa  and  pyrimidine) 
intended  for  use  in  treating  certain  infections,  particularly  kidney 
infections. 

I  also  understand  that  the  drug  has  already  been  given  to  several 
thousand  people  in  the  world  without  causing  any  known  serious  reactions 
However,  as  with  all  medicines,  I  know  that  there  is  a  slight  chance  of 
a  serious  drug  reaction. 

I  further  understand  that  the  only  purpose  for  this  drug  study  is 
to  determine  how  well  the  drug  is  absorbed  into  my  system  and  the  time 
required  for  it  to  pass  out  through  my  kidneys.  The  entire. study  will 
last  two  weeks  and  will  require  four  days  of  my  time  each  week.  I  will 
take  one  dose  of  the  drug  each  week  and  will  permit  specimens  of  my 
blood  to  be  drawn  at  least  18  times  over  the  2-week  study  period. 

Finally,  if  I  so  desire,  I  may  discontinue  my  activities  in  this 
drug  study  before  it  is  completed. 


941 


Deer  Lodge  Research  Unit 
Volunteer  Consent  Form 
DL-09-72,  Cont. 


I  have  read  all  the  information  above  and  it  has  been  read  aloud 
to  me  by  Dr.  James  D.  Moore.  I  was  given  an  opportunity  to  ask  ques- 
tions and  I  fully  understand  and  agree  to  the  contents  of  this  form. 


Right  Thumb  Print 


Sign  here  above  line 


M.S. P.  Number 


942 


UNIVERSITY  OF  MONTANA  FOUNDATION 
DEER  LODGE  RESEARCH  UNIT 

DL-13-72 

VOLUNTEER     CONSENT     FORM 
Date: 

I  hereby  volunteer  to  participate  in  this  drug  testing  study  and  also  to 
submit  myself  for  medication  promptly  as  scheduled. 

I  have  been  advised  that  the  medicine  is  being  used  for  investigational 
purposes  and  it  is  a  new  type  of  tranquilizer  in  the  experimental  stage  of  human 
testing.     I  understand  that  this  new  medicine  may  eventually  be  used  for  treat- 
ing patients  with  convulsive  seizures.     However,  I  understand  that  there  are  no 
expected  benefits  to  my  health  from  taking  the  medicine. 

I  also  understand  that  the  medicine  may  cause  drowsiness,  dizziness,  stag- 
gering, slurred  speech,  blurred  vision  or  feelings  of  faintness. 

I  further  understand  that  the  main  purpose  of  this  drug  study  is  to  determine 
the  time  required  for  the  drug  to  be  absorbed  into  my  blood  stream  and  the  time 
required  for  passing  out  through  my  kidneys.     These  determinations  will  require  my 
giving  12  blood  specimens  and  two  24-hour  urine  specimens  during  the  2-day  project. 

Finally,  if  I  so  desire,  I  may  discontinue  my  activities  in  this  drug  study 
before  it  is  completed. 

I  have  read  all  the  information  above  and  it  has  been  read  aloud  to  me  by 
Dr.  James  D.  Moore.     I  was  given  an  opportunity  to  ask  questions  and  I  fully 
understand  and  agree  to  the  contents  of  this  form. 


Right  Thumb  Print 


Sign  here  above  line 


M.  S.   P.  Number 


943 

UNIVERSITY     OF     MONTANA     FOUNDATION 

BOARD  OF  REVIEW 


Chairman: 


Members : 


Norman  E.  Taylor,  Ph.D. 
Phone:     243-2311 


Carl  L.   Larson,  M.D. 

Phone:  243-4392 
Thomas  J.  Collins 

Phone:  243-2593 
Roger  W.  Crist 

Phone:  846-1320,  Ext.  31  (Deer  Lodge) 
Charles  P.  Brooke,  M.D. 

Phone:  549-6411 
Rev.  William  J.  Kliber 

Phone:  728-2537 
Robert  L.  Van  Home 

Phone:  243-4621 


944 


UNIVERSITY   OF   MONTANA   FOUNDATION 


BOARD  OF  REVIEW 


Individual  Data 


NAME  6  ADDRESS: 

Norman  E.  Taylor 

2404  Glen  Drive 
Missoula,  Montana  59801 


PHONE: 


243-2311  (office) 


EDUCATION 


University  of  California,  Berkeley,  A.B.,  1941. 
University  of  California,  Berkeley,  M.B.A.,  1947. 
University  of  Minnesota,  Minneapolis,  Ph.D.,  1955. 


PRINCIPAL  OCCUPATION  ^  APPOINTMENTS: 


Vice  President  for  Research,  University  of  Montana,  1968  to  present. 
Research  Director,  University  of  Montana  Foundation,  1968  to  present 
Administrative  Vice  President,  University  of  Montana,  1967-68. 
Director,  Bureau  of  Business  and  Economic  Research,  University  of 

Montana,  1965-67. 
Associate  Director,  Bureau  of  Business  and  Economic  Research, 

University  of  Montana,  1964-65. 
Associate  Professor,  School  of  Business  Administration,  University 

of  Montana,  1962-64. 


945 

UNIVERSITY   OF   MONTANA   FOUNDATION 

BOARD  OF  REVIEW 

Individual  Data 

NAME  &  ADDRESS: 

Carl  Leonard  Larson,  M.D. 

2340  Cloverdale  Drive 
Missoula,  Montana  59801 

PHONE: 

243-4392 

EDUCATION: 

Montana  School  of  Mines,  Butte,  Montana,  1926-28 
Montana  State  College,  Bozenian,  Montana,  1929-32,  B.S. 
University  of  Minnesota,  Minneapolis,  Minnesota,  1933-39,  M.D. 

Honorary  Doctor  of  Science  Degree,  1954,  University  of  Montana 

PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Inmunologist 

Director,  Rocky  Mountain  Laboratory,  NIH,  Hamilton,  Montana 

1950-61 
Visiting  Scientist,  Pasteur  Institute,  Paris,  France 

1960-61 
Professor,  Department  of  Microbiology,  University  of  Montana, 

1962  to  present. 
Director,  Stella  Duncan  Memorial  Institute,  University  of  Montana 

1962  to  present. 


946 

UNIVERSITY   OF   MONTANA   FOUNDATION 

BOARD  OF  REVIEW 

Individual  Data 

NAME  &  ADDRESS: 

Thomas  J.  Collins 

Old  Pond  Road-Rattlesnake 
Missoula,  Montana  59801 

PHONE: 

243-2593 

EDUCATION: 

Ohio  State  University,  Columbus,  Ohio,  B.S.,  Business  Administration 
1946 

PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Director,  University  of  Montana  Foundation 


947 

UNIVERSITY     OF     MONTANA     FOUNDATION 

BOARD  OF  REVIEW 

Individual  Data 

NAME  &  ADDRESS: 

Roger  W.   Crist 

300  Maryland 

Deer  Lodge,  Montana  59722 

PHONE: 

846-1320,  Extension  #31 

EDUCATION: 

University  of  Minnesota,  1952  -  1956,  B.A.  Degree,  double  major 

Psychology  and  Sociology. 
University  of  Minnesota,  1956  -  1957,  graduate  school,  major 

Sociology,  minor  Psychology. 
University  of  Wisconsin,  1960  -  1961,  Master  Degree  in  Social  Work, 

PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Warden,  Montana  State  Prison 


948 

UNIVERSITY     OF     MONTANA     FOUNDATION 

BOARD  OF  REVIEW 

Individual  Data 

NAME  &  ADDRESS: 

Charles  Patrick  Brooke,  M.D. 

445  S.  5th  W. 

Missoula,  Montana  59801 

PHONE: 

549-6411 

EDUCATION: 

Carroll  College,  Helena,  Montana,  1934-37,  B.S. 

St.  Louis  University,  School  of  Medicine,  St.  Louis,  Missouri,  M.D, 

1937-41 
University  of  Montana  Law  School,  Missoula,  Montana,  1958-64, 

Juris  Doctor 

PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Physician  and  Surgeon 

Consulting  surgeon,  Burlington-Northern  Railroad 

President,  Montana  State  Board  of  Medical  Examiners 

Licensed  Attorney-at-Law 

Medical -Legal  Consultant 

Lecturer  on  Medical -Legal  Law,  University  of  Montana  Law  School 


949 

UNIVERSITY  OF  MONTANA  FOUNDATION 

BOARD  OF  REVIEW 

Individual  Data 

NAME  &  ADDRESS: 

William  John  Kliber 

530  Keith  Ave. 
Missoula,  Montana  59801 

PHONE: 

543-4092  (office) 

EDUCATION: 

Syracuse  University,  B.A.,  1952 
Yale  University,  B.D.,  1955 
Yale  University,  S.T.M.,  1968 

PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Pastor,  First  United  Methodist  Church,  Missoula,  Montana 


93-999  O  -  73  -  pt.  3  —  11 


950 

UNIVERSITY       OF       MONTANA       FOUNDATION 

BOARD  OF  REVIEW 
Individual  Data 

NAME  &  ADDRESS: 


Robert  L.  Van  Home 

4  Martha's  Court 
Missoula,  Montana     59801 


School  of  Pharmacy 
University  of  Montana 
Missoula,  Montana    59801 


PHONE: 


549-2152  (Home) 
243-4621  (Office) 


EDUCATION: 


State  University  of  Iowa,  B.  Sc.  in  Pharmacy,  1941 
State  University  of  Iowa,  M.  Sc.  in  Pharmacy,  1947 
State  University  of  Iowa,  Ph.  D.  in  Pharmacy,  1949 


PRINCIPAL  OCCUPATION  &  APPOINTMENTS: 

Dean  and  Professor,  School  of  Pharmacy,  University  of  Montana 

Chairman,  Advisory  Council  on  Alcohol  and  Drug  Dependence  to  Montam 
Department  of  Health  and  Environmental  Sciences. 


951 

UNIVERSITY  OF  MONTANA  FOUNDATION 
DEER  LODGE  RESEARCH  UNIT 

SCHEDULE  OF  PAYMENTS  TO  VOLUNTEERS 

Venipuncture  (blood  specimen) $1.00  ea 

Ward  Day  (24-hour  admission  3.00/day 

to  Special  Study  Ward— does 
not  include  venipunctures) 

Oral  Medication  ...  0.25/dose 

Intramuscular  Medication  1.00  ea 

Topical  Medication  (skin  surface)     ....     1.00/day 


After  a  volunteer  enters  a  trial,  minimum  daily  payment 
will  not  be  less  than  $0.50  per  day,  irrespective  of  his 
contribution  to  the  trial.  This  means  that  the  minimum 
payment  will  be  paid  even  if  the  volunteer  is  only  in  a 
"holding"  status  between  drug  doses. 


f   . 


952 


CONSENT  FORM 

UNIVERSITY  OF  MARYLAND  SCHOOL  OF  IffiDICINE  AND  HOSPITAL 
BALTIMORE,  I^ARYLAND 


Patient's  Name: 


This  is  to  certify  that  I  agree  to  participate  in  the  following  program 
of  study  \jnder  the  care  and  sxxpervision  of  Russell  R,  Monroe,  M.D,      I  have 
been  informed  that  this  study  will  include  two  electroencephalographs  and  a 
period  of  four  to  six  months   during  which  I  will  receive  medication.     It  will 
also  include  several  interviews  with  the  investigators  as  well  as  psychological 
testing,     I  also  give  pemiasion  to  the  investigators  to  review  ny  records 
in  the  possession  of  the  Patuxent  Institute,      It  is  ay  understanding  that  I 
will  receive  conroensation  of  fifty  cents   ($   ,50)  x>er  day  for  the  period  of  the 
experiment,  and  that  all  the  research  data  will  be  confidential  and  not  avail- 
able to  anybody  but  the  investigators, 

I  fiilly  understand  the  propran  of  study  end  the  procedures  which  will  be 
performed,      I  have  had  an  adequate  chance  to  ask  questions  and  I  may  ask  at 
any  tir.e  while  the  study  is   in  progress, 

I  understand  that  I  am  free  to  xrithdraw  rjr  consent  and  discontinue  my 
participation  in  the  stucty  at  any  time.     If  I  do  discontinue,  this  will  not 
limit  ny  oi^nortunity  to  receive  services  offered  b;/  the  University  of  Maryland 
Hospital  or  School  of  Medicine  other  than  those  which   are  pert  of  the  study. 


Date  Signature  of  Patient  or  authorized 

repr e  sen tati  ve • 


I  have  f\illy  expledned  to  the  patient 


the  natxire  and  purpose  of  the  procedures  described  above  and  such  risks,  as  are 
involved  in  their  performance. 


Date  Physician's  Signature 

^e  foregoing  is  an  accurate  sisomary  of  the  explanation  which  vas  made  to 
the  patient  and  the  undersigned  witnessed  the  signature. 


Date  Signatxire  of  Audltor^Witness 


953 


STATEMENT  OP  MERLE  GOLDBERG,    DIRECTOR,    NATIONAL  WOMEN'S 
—{ HEALTH   COALITION  — - 


I  am  Merle  Goldberg,  executive  director  of  the  National  Women's 
Health  Coalition .     The  National  Women's  Health  Coalition  has  arranged  free 
abortions  and  other  medical  care  for  more  than  10,000  women  in  the  last  five 
years.    In  early  May,  1972,  I  received  a  call  from  a  women's  hesdth  group  in 
Chicago  asking  us  to  arrange  free  abortions  for  250  women  who  were  unable  to 
obtain  them  in  Illinois.     Of  these,  40  subsequently  obtained  abortions 
elsewhere.     There  was  little  difficulty  in  arranging  about  180  others, 
as  those  women  were  in  their  first  trimester  of  pregnancy,  and  clinics 
in  New  York  and  Washington,  D.C.  responded  generously  to  the  emergency. 
The  NWHC  arranged  free  saline  abortions  in  New  York  hospitals  for  about 
10  women,  each  of  whom  could  afford  to  fly  to  New  York  as  soon  as  the 
free  saline  procedure  become  available. 

Women's  groups  in  New  York,  Chicago,  and  Philadelphia  were  then 
confronted  with  20  women  who  had  no  money  for  transportation  or  for  an  abor- 
tion, and  who  needed  second  trimester  abortions  on  an  emergency  basis.     All  of 
them  had  to  be  taken  care  of  in  one  day  as  the  Chicago  women's  group  had 
chartered  a  bus  so  that  the  cost  of  round  trip  transportation  would  be  $25 
for  each  woman  instead  of  $114.     The  women  had  to  have  the  abortions  on 
a  weekend,  since  neither  they  nor  the  persons  watching  their  children  could 
afford  to  lose  a  day's  wages. 

Six  days  were  spent  attempting  to  arrange  these  20  abortions  in 
New  York.     Every  attempt  failed,  although  more  than  50  New  York  women  had 


954 


promised  their  homes  and  time  to  help  the  Chicago  women.     New  York 
municipal  hospitals  were  banned  by  law  from  helping  out-of-state  women. 
One  hospital,  which  was  willing  to  cooperate  with  the  women's  groups, 
was  seriously  considering  using  the  coil  as  an  out-patient,   second  trimester 
technique  under  the  direction  of  a  physician  considered  to  be  an  expert  in  second 
trimester  techniques.     This  physician  obtained  preliminary  approval  from 
the  New  York  City  Department  of  Health  to  waive  the  in-patient  requirement 
concerning  second  trimester  procedures.      (This  was  not  an  unusual  request,  as 
two  of  the  city's  municipal  hospitals  were  doing  salines  on  an  out-patient 
basis  with  good  safety  records.)     But  the  person  whose  approval  was  mandatory 
was  out  of  town  for  three  weeks ,  and  the  Chicago  women  could  not  wait . 

When  it  became  apparent  that  legal  abortions  could  not  be  obtained 
for  the  last  20  women  in  New  York,  a  Philadelphia  physician.  Dr.  Barron  Gosnell. 
agreed  to  perform  the  abortions  free  of  charge  in  his  clinic,  using  the  supercoil 
technique .   A  Los  Angeles  physician  agreed  to  participate  and  flew  to  Philadel- 
phia at  his  own  expense .     The  Philadelphia  doctor  asked  that  Dr .  Harvey  Karman 
be  brought  in  as  a  consultant.     Dr.  Karman  agreed  and  also  flew  in  at  his  own 
expense . 

Although  the  physicians  had  not  performed  a  supercoil  abortion  before . 
many  aspects  of  this  technique  were  familiar  to  both  doctors  .    Insertion  and  re- 
moval of  the  super  coil  is  essentially  the  same  as  insertion  and  removal 
of  the  contraceptive  intrauterine  device,  something  with  which  most  gynecologists 


955 


have  had  extensive  experience.    In  fact.  Dr.  Gosnell  points  out  that  "the  method 
is  an  extremely  old  one .  it  has  been  a  known  abortifacient  for  centuries .    It  was 
_a-simple  matter "  ^ Dr ^Gosnell-says  "of  knowing  that  soft,  sterile  material  was 
better  to  achieve  a  miscarriage  than  hard .  rigid  material . "    (See  Appendix  A . ) 

At  this  point  it  is  also  important  to  explain  the  di^erences  between  the 
super  coil  and  the  other  mechanical  techniques ,  on  the  one  hand .  and  saline  and 
other  chemical  techniques  on  the  other .    The  coll .  like  the  Japanese  catheter 
balloon,  causes  the  placenta  to  become  detached  from  the  wall  of  the  uterus,  re- 
sulting in  labor  and  expulsion  of  the  fetus  -  a  miscarriage .    The  saline  procedure 
achieves  the  same  end  through  chemical  means .    Once  the  miscarriage  begins 
(whether  the  abortifacient  was  mechanical  or  chemical)  whatever  happens  at 
that  point  is.  again  as  famUiar  to  an  obstetrician- gynecologist  as  insertion  of  an 
Jnlrauterine  device .   Upon  consultation  with  Dr .  Karman  the  two  physicans  were 
able  to  make  the  transition  to  the  super  coil  abortion . 

Even  Dr.  Karman,  the  developer  of  the  coil,  understands  that 
the  coil  was  not  intended  as  a  definitive  answer  in  abortion  technology. 
At  a  recent  conference  he  presented  the  following  history  of  the  coil. 
"Both  the  super  coil  and  the  cannula  evolved  out  of  the  efforts  from  more 
than  20  years  ago  to  find  safer  technology  for  the  termination  of  unwanted 
pregnancy."     At  the  time  it  was  virtually  impossible  for  women  to  obtain 
abortions  from  reputable  physicians,  with  fees  ranging  from  $500  in  Mexico 
up  to  $2,500  in  California;   the  problem  was  compounded  with  students 
and  other  young  women  with  limited  incomes. 


956 


"Self- induced  and  incompetent  abortions  have  caused  many  complications 
and  an  unknown  number  of  fatalities.     After  considerable  research,  it  became 
apparent  that  the  available  medical  literature  about  abortions  was  filled  with 
contradiction  and  misconceptions.     The  coil  was  an  attempt  to  improve  the 
catheter  technique,  commonly  used  in  Mexico.     A  rubber  catheter  was 
introduced  into  the  uterine  cavity  and  would  cause  a  miscarriage  within  3  or 
4  days,  but  infection  was  common.     The  coil,  because  it  was  kinetic, 
instead  of  static,  usually  worked  within  24  hours  and  rarely  required  additional 
treatment.     Thousands  of  coil  terminations  were  performed  in  the  years 
before  the  Supreme  Court  decision  of  January  22,   1973  which  finally  recognized 
a  woman's  right  not  to  have  an  unwanted  child.     Because  until  recently 
most  states  had  passed  laws .  which  were  in  conflict  with  the  constitution. 
It  was  impossible  to  conduct  the  type  of  research  necessary   to  document 
empirical  results.     As  the  laws  became  more  liberalized,  more  and  more 
physicians  expressed  an  interest  in  an  alternative  to  saline  infusions/the 
coil  has  been  demonstrated  at  a  number  of  hospitals,  and  occasionally 
employed  after  an  attempt  at  saline  induction  had  failed. 

"Now  that  the  legal  barriers  to  abortion  have  been  removed  and  the 
dangers  of  szdine  infusion  have  become  more  apparent,  it  is  hoped  that 
funds  will  be  provided  for  a  comprehensive  study  comparing  mechanical  vs. 
chemical  techniques  in  the  second  trimester." 

To  deal  with  the  points  raised  by  Dr .  Wolfe: 


957 


There  were  complications  but  as  the  report  of  the  Center  for 
Disease  Control  points  out,  many  factors  besides  the  coil  could  have 
caused  the  complications .     This  was  a  most  important  acknowledgement 
on  the  part  of  the  CDC.  but  Dr.  Wolfe  chose  to  ignore  it. 

Case  1: 

If  the  perforation  had  occurred  when  the  coils  were  inserted,  or 
when  they  were  in  the  uterus,  the  corresponding  hemorrhage  would  have 
been  marked  by  a  precipitous  decline  in  blood  pressure.     This  did  not 
happen.     Therefore,  in  the  opinion  of  the  two  physicians  who  performed 
this  procedure,  the  perforation  occurred  after  the  coils  were  removed, 
and  was  caused  by  use  of  metal  instruments  to  remove  the  products  of 
conception.     The  use  of  metal  instruments  is  standard  in  connection  with 
saline  procedures,  incidentally,  and  complications  resulting  from  this 
use  can  occur  even  under  ideal  hospital  conditions. 

Case  2: 

The  abdominal  surgery  Dr.  Wolfe  refers  to  occurred  two  and  one 
half  weeks  after  the  abortion  was  performed.     It  was  related  to  two 
problems:   pelvic  inflammatory  disease   (which  the  woman  knew  she  had 
before  she  left  Chicago)  and  suspected  appendicitis.     It  was  not  related  to  the 
abortion.     The  CDC  report  describes  this  as  follows: 


5. 


958 


"The  day  following  her  return  to  Chicago,  the  patient  was  hospitalized, 
complaining  of  severe  abdominal  pain .    She  was  treated  with  antibiotics  in  the 

hospital  for  10  days  for  suspected  acute  pelvic  inflammatory  disease.    Uterine 

curettage  recovered  no  retained  products  of  conception.    (Ed.  Note:    This  meant 
that  the  abortion  was  complete.)    One  week  following  discharge  from  the  hos- 
pital ,  the  patient  was  again  admitted  with  fever ,  severe  abdominal  pain ,  and 
signs  of  peritoneal  irritation . 

"Laparotomy  was  performed  because  of  a  preoperative  diagnosis  of 
acute  appendicitis.   At  surgery,  pelvic  adhesions  were  noted,  as  was  a  normal 
appearing  appendix .    Pathologic  examination  revealed  mild  periappendeceal 
inflammation .    The  postoperative  diagnosis  was  endometritis  with  intrapelvic 
adhesions .     Following  a  second  10-day  course  of  antibiotic  therapy  in  the 

ho^ital,  the  patient  was  discharged  improved  on  May  14,   1972,  one  month 

after  her  induced  abortion." 

It  is  our  underst£^nding ,  based  on  consultation  with  gynecologists, 
that  these  signs  and  symptoms  were  related  either  to  ZHsarpelvic  inflammatory 
disease  or  to  the  inflammation  surrounding  the  appendix,  and  were  not  related 
in  any  way  to  the  abortion. 

Although  Dr .  Wolfe  must  have  been  well  aware  of  the  contents 
of  the  CDC  report,  all  he  chose  to  say  about  this  aspect  of  Case  2  was  that 
the  woman  "was  hospitalized  after  returning  to  Chicago  because  of  severe 


959 


abdominal  pain.     She  too  required  abdominal  surgery."     He  thus  gave 
the  totally  false  impression  that  this  surgery  was  necessitated  by 
complications  of  the  abortion. 

Case  3: 

In  this  single  instance.  Dr.  Wolfe  accurately  reported  the  CDC 
conclusions,  with  which  we  are  in  essential  agreement.     Among  the 
minor  complications  Dr.  Wolfe  cited  was  elevated  fever  in  seven  cases. 
This  is  not  a  significant  complication  to  the  patient  and  is  quite  common 
during  a  saline  procedure  and  usually  goes  unreported. 

We  ^gree  completely  with  the  following  CDC  recommendations  for 
the  testing  of  new  abortion  techniques^  and  would  welcome  any  attempt  to 
create  these  conditions. 

"That  initial  testing  of  new  abortion  methods  to  be  conducted  only 
following  a  detailed  research  protocol  under  careful  scientific  and  medical 
supervision  and  in  a  hospital  environment  with  adequate  personnel  and 
focilities  to  diagnose  and  treat  any  complications  that  might  arise .     Patients 
-willing  to  accept  the  written  application  of  new  methods  should  demonstrate, 
tiirough  written  and  informed  consent,  thorough  understanding  of  the  investi- 
gative^ nature  of  new  methods  and  their  potential  risks . " 


We  hope  that  the  Supreme  Court  decision  of  January  22.   1973  will 
]    ,  )   ,  ■ 

make  this  recommendation  feasible'. 


t         '■  ■>         ' 


960 


To  deal  with  some  other  statements  made  by  Dr .  Wolfe  -  he  doubts 
whether  the  women  were  informed  of  the  risks.     Had  he  bothered  to  contact 
any  of  the  women  involved ,  he  would  have  found  out  that  they  were  informed 
of  every  aspect  of  the  procedure  and  the  possible  risks  before  leaving 
Chicago;   that  they  were  accompanied  to  Philadelphia  by  women  counselors; 
were  coxinseled  again  in  Philadelphia;   and  were  accompanied  back  to 
Chicago  by  these  counselors  and  by  the  two  physicians  who  had  performed 
the  abortions. 

Dr.  Wolfe's  description  of  the  coil  presents  an  incongruous  picture 
of  a  "13  inch  shoelace",   Implying  a  long,  thin,  rigid  piece  of  plastic 
which  could  cause  perforations.     Actually,  before  insertion,  the  coil 
is  tightly  wound  to  about  the  diameter  of  a  25  cent  piece.     During  insertion 
it  straightens  out  long  enough  to  go  through  an  insertion  tube  into  the  uterus. 
Here  it  resumes  its  coiled  shape,  slightly  looser  and  larger  in  diameter 
than  its  original  form.     One  of  Dr.  Wolfe's  anonymous  "leading  experts" 
believes  that  the  coil  is  "not  based  on  sound  physiologic  principles". 
Evidently  he  is  not  aware  that  the  contraceptive  lUD  operates  on  those  same 
principles,  and  is  considered  by  every  gynecologist  to  be  an  abortifacient . 
.We  do  not  know  that  those  who  have  used  the  coil  in  the  U.S.  and  abroad 
feel  that  the  super  coil  is  a  promising  device  which  merits  further  research. 

In  June,   1971  International  Planned  Parenthood  Federation's  Experts 
on  Abortion  panel  met  in  Novi  Sad,  Yugoslavia  and  had  this  to  say  in 


961 


their  report.     "Injection  of  saline  into  the  amniotic  sac  induces  an  abortion 
12  to  36  hours  later.     It  is  a  two  stage  technique  and  may  require  surgical 
1r«t#»rventior.  to  remove  retained  products  of  conception.     It  is  emotionally 
traumatic  to  the  patient  and  can  be  upsetting  to  the  nursing  staff. . . 
Severe  electrolyte  imbalance  or  cases  of  cerebral  damage,   shock  or 
uterine  rupture  may  occur  following  saline  induction.     Hypofibrinogenaemia 
may  follow  fetal  death  and  lead  to  severe  hemorrhage  at  the  time  of 
abortion . . .     The  introduction  of  foreign  bodies  between  the  uterine 
wall  and  the  embryonic  membranes  has  long  been  used  as  an  illegal  method 
of  abortion .     The  use  of  one  or  more  sterile ,  expanding  plastic  devices 
(Karman  super  coils)  inserted  through  the  cervix  to  lie  outside  the 
membrane  has  shown  promise  in  certain  circumstances." 

Robert  Bragonier,  M.D.  of  the  Department  of  Obstetrics  and 
G3^ecology.  Harbor  General  Hospital,  Los  Angeles,  reported  in  the 
May  12,  1972  issue  of  Medical  World  News  that  his  trials  with  the 
coil  showed  that  the  coil  promised  to  reduce  the  danger  of  infection 
and  hemorrhage  in  the  second  trimester.     Similarly,  Lee  D.  Newman,  M.D. 
of  San  Vicente  Hospital  in  Los  Angeles   (see  Appendix  B)  concluded  after 
-his -study  with  32  terminations  with  the  coil  that  "the  simplicity  of  the 
procedure  suggests  that  it  has  broad  applications  in  many  areas.".     Most 
importantly,  perhaps,  the  statement  of  George  J.  Langmyhr,  M.D., 
Executive  Secretary  of  the  American  Association  of  Planned  Parenthood  Physi- 
cians is  relevant.     Dr.  Langmyhr,  asked  to  comment  on  the  Center  for  Disease 
Control  report  by  the  National  Women's  Health  Coalition,  lb  said:      "I  was 


962 


particularly  interested  in  the  Center  for  Disease  Control  investigation  which 
seems  to  be  very  fair  and  positive.     It  seems  to  recognize  the  urgency 
of-the  situation  confronting  the  20  women  who  had  come  to  Philadelphia 
for  their  mid-trimester  abortions,   while  at  the  same  time  recognizing 
that  various  factors  might  have  been  better  controlled.     I  would  be 
most  interested  to  know  if  the  super  coil  is  going  to  be  investigated  in 
any  form  or  way.     I  would  hope  it  would,   since  it  could  very  well  be  an 
important  abortive  method." 

Dr.  Langmyhr  seems  to  realize  as  Dr.  Wolfe  does  not,  that  there 
is  an  urgent  need  for  simple,  safe  second  trimester  termination  technology. 

Dr.  Wolfe  referred  to  Bangladesh,   where  the  coil  was  effectively  used 
to  save  thousands  of  women's  lives.     The  statistics  available  on  the  emergency 
relief  are  minimal  as  this  was  an  attempt  to  save  the  lives  of  young  women  - 
some  as  young  as  10  and  11  -  who,  if  they  had  been  allowed  to  carry 
to  the  full  term ,  would  have  died  since  their  pelvic  structure  was  too  small 
to  carry  to  the  full  term.     We  do  know  from  Malcolm  Potts,  M.D., 
medical  director  of  International  Planned  Parenthood  Federation,  that  at 
least  1800  women  were  aided  by  the  emergency  relief  team  he  directed, 
and  which  included  Dr .  Karman .     We  also  know  from  the  Bangladesh  women 
in  charge  of  the  emergency  relief  project,   sanctioned  and  encouraged  by 
the  Prime  Minister  that  many  more  than  1800  abortions  were  effected  after 
the  emergency  relief  team  left  the  country. 


963 


11, 


It  is  unfortunate  that  Dr.  Wolfe,  instead  of  encouraging  a 
comparative  study  of  second  trimester  techniques  would  attempt  to 
fxlghten  doctoi/'  away  from  seeking  better  methods  of  terminating 
pregnancies.     In  his.  at  best,  unthinking  haste,  he  has  helped 
condemn  more  women  to  procedures  we  know  are  inadequate.     He 
has  served  to  frighten  the  medical  profession  away  from  doing  most 
desperately  needed  abortion  research. 

Dr.  Wolfe  is  totally  unaware  that  the  saline  procedure  is  being 
rejected  throughout  the  world  as  a  second  trimester  technique  because 
it  is  associated  with  a  high  rate  of  serious  complications.     In  Japan, 
mechanical  intervention  is  being  used  as  an  alternative  technique.     We, 
as  women,  are  unhappy  that  more  attention  is  not  being  paid  to  abortion 
research,  to  help  the  50  million  women  who  have  abortions  each  year  throughout 
the  world .     The  NWHC  strongly  supports  the  goal  of  device  control .     But  it 
is  suspect  that  Dr .  Wolfe  would  choose  this  single  emergency  situation 
as  an  example  rather  than  situations  which  we.  as  women,  are  most 
familiar  with.     Why,  for  example,  did  he  not  choose  the  mass  marketing  of  the 
Dalkon  Junior  Shield  -  a  ccmtraceptive  intrauterine  device  that  had  such  a 
failure  rate  -  especially  since  there  was  no  need  or  urgency  to  market 
that  particular  device.     Or  the  study  of  the  Safe-t-coil,  another  contraceptive 
lUD  which,  according  to  a  study,  was  used  on  mentally  retarded  women  in 
Dade  County.  Florida,  as  an  interim  technique  until  they  could  be  sterilized. 


*See  Appendix  C. 


964 


Resistance  to  new  abortion  techniques,  for  some  reason, 
has  been  especially  vehement.     In  1970,   as  executive  director  of 
the  Women's  Medical  Center  -  the  first  government-licensed  out-patient 
abortion  clinic  in  the  country,   I  suggested  to  gynecologists  that  it  might  be 
possible  to  do  an  abortion  using  the  Karman  cannula  and  other  developments  of 
Dr.  Karman  to  minimize  the  trauma  of  abortion  by  eliminating  the  need  for 
general  anesthesia  in  all  cases,   local  anesthesia  in  most  cases  and  cervical 
dilation,  which  leacyto  significant  complications. 

I  was  told  that  it  was  impossible ,  experimental ,  dangerous ,  etc .     This 
was  told  to  me  by  many  gynecologists,  despite  the  fact  that  many  women  were 
receiving  those  abortions  with  minimum  complications  at  reasonable  prices.     The 
Karman  procedure  promised  lessening  the  trauma  of  abortion  by  eliminating 
rigid  instrumentation  and  dangerous  techniques.     Now,  atraumatic 
abortion  and  menstrual  extraction  is  accepted  world-wide,  and  a  number  of 
clinicians  have  duplicated  Dr.  Karman' s  reports  of  significantly  lower 
morbidity . 

It  was  not  Dr.  Karman's  "enthusiasm"  that  led  to  widespread 
availability  or  the  use  of  the  atraumatic  first  trimester  abortion  techniques. 
It  was  the  demand  of  women  that  the  medical  profession  utilize  those  techniques. 
It  has  taken  us  ten  very  long,  hard  years  to  convince  the  medical  profession 
to  accept  the  simple  principle  that  when  doing  a  blind  procedure   (such  as  a 
first  trimester  abortion)  in  a  soft  curved  organ   (the  uterus)  it  might  be 


965 


better  to  use  soft,  flexible  curved  instruments  as  opposed  to  a  straight, 
steel  rod. 

Similarly  with  the  coiljin  hospitals  both  in  New  York  and  in 
Los  Angeles,   where  patients,  nurses  and  women  counselors  have  seen 
the  more  than  500  coil  procedures  under  ideal  conditions   (as  opposed 
to  the  emergency  situations) ,  they  have  asked  the  doctors  to  investigate 
the  coil  further  because  the  women  apparently  experience  less  trauma 
with  this  procedure  than  with  the  saline  procedure. 

Because  of  Dr.  Karman's  contributions,  abortions  are  now  $25  in  Los 
Angeles,  from  $35  to  $50  in  New  York  and  throughout  the  rest  of  the  country. 
Many  gynecologists  feel  that  the  atraumatic  first  trimester  procedures  can  be 
safely  dealt  with  by  paramedics .     In  fact .  in  two  centers  in  this 
country  and  one  abroad,  paramedics  are  already  being  trained  in  this 
procedure.     Women's  groups  cannot  help  but  suspect  that  the  possibility 
of  safe,  low-cost,  widely- available  abortions  to  all  women  is  a  threatening 
proposition  to  many  doctors  and  hospitals,  and  accounts  in  no  small  measure 
for  the  vitriol  Dr.  Karman  has  been  subjected  to  throughout  the  20  years 
he  has  devoted  to  developing  non-traumatic  abortion  techniques. 

As  to  the  contributions  of  Dr .  Karman ,  who  two  years  ago  was  honored 
by  a  resolution  of  the  National  Task  Force  on  Reproduction  and  its  Control 
of  the  National  Organization  for  Women  for  his  work  over  20  years ,  I  would 


13. 


93-999  O  -  73  -  pt,  3  —  12 


966 


14 


like  to  quote  Leonard  E.  Laufe,  M.D.,   Chief  -  Division  of  Obstetrics  and 
Gynecology,  Western  Pennsylvania  Hospital,   who  was  in  Bangladesh  with 
Dr.- JCarman,   "I -feel  it  appropriate  to  go  on  record  on  behalf  of  Harvey 
Karman.     He  accompanied  me  to  Bangladesh  at  the  end  of  February  and  early 
March  of  this  year  in  order  to  establish  an  abortion  clinic  for  the  rape  victims 
of  the  Bangladesh  war .     Harvey  Karman  is  a  recognized  innovative  technician 
who  came  along  as  a  technological  consultant.     He  never  practiced  medicine  or 
made  an  attempt  to  in  my  presence,  but  has  brought  to  medicine  a  new  era  of 
technological  advances  for  the  induction  of  safe  pregnancy  termination.     Harvey 
Karman  is  recognized  internationally .     There  are  many  formal  publications  which 
bear  his  name  describing  the  equipment  which  he  has  designed  and 
which  had  been  proved  to  be  safe  and  effective.     He  is  used  as  a 
consultant  by  International  Planned  Parenthood  Federation  through  its 
London  offices.     He  has  sat  on  government-sponsored  medical  advisory 
research  committees  at  Battelle  Northwest,   for  the  improvement  of 
the  technology  of  pregnancy  terminations.     He  has  no  peer,  as  far 
as  I  am  concerned  in  the  development  of  new  instrumentation  to  make 
pregnancy  termination  and  contraception  safe  for  women." 

Jack  Lippes.  M.D.,  developer  of  the  Lippes  Loop,  describes  Dr.  Karman 
as  "a  dedicated  and  idealistic  scientist",  who  "has  made  important  scientific 
contributions  to  medicine." 

Edward  Stim,  M.D.,  instructor  at  the  Albert  Einstein  College 
of  Medicine .  describes  Dr .  Karman  as  "one  of  the  world's  experts  on 


967 


abortion  techniques .    He  is  the  inventor  of  the  Karman  cannula ,  which  has 
revolutionized  early  abortion  techniques  due  to  its  extreme  simplicity  and 
safety.    Dr.  Karman's  advice  has  been  invaluable  to  me  on  many  occasions 
when  I  have  consulted  with  him  concerning  the  problems  of  abortion . " 

We  do  not  want  to  turn  this  into  a  contest  of  leading  experts 
nor  do  we  know  if  the  coil  is  the  second  trimester  answer .    We  do 
know  that  saline  is  not.    We  ask  -  just  as  the^^D  and  Dr.  Wolfe  do  - 
that  there  be  more  abortion  research  under  better  circumstances.     But  we 
ask  one  thing  more  -  that  any  of  this  research  be  conducted  with 
consumers,  i.e.  women  participating.     We  regret  that  there  was  not  time 
during  that  May  weekend  to  fully  inform  all  of  the  Philadelphia  women's 
groups.     But  the  Chicago  women  were  fully  informed,   and  in  subsequent 
months  a  number  of  panels  were  arranged  by  women's  groups  in 
Philadelphia  to  discuss  the  incident  and  most  of  their  questions  were 
answered. 

We  agree  with  the  Philadelphia  collective  that  all  information  on 
research,  experimentation  and  new  devices  require  that  an  open  channel  of 
honest  communication  be  established  between  consumers  and  the 
medical  industry. 

As  a  group  which  has  spent  the  last  three  years  monitoring  abortion 
clinics;   which  has  seen  medically-sanctioned  carelessness  and  indifference; 


15, 


968 


which  each  day  has  to  deal  vnth  and  help  women  who  have  been  lied  to, 
mistreated  or  are  the  victims  of  these  practices  and  indifference,  we 
know  a  great  deal  about  the  abortion  industry.     There  are  hundreds  of 
case  histories  of  real  medical  maltreatment  on  record  and  we  would 
welcome  a  chance  to  share  this  information  with  this  sub -committee  or  with 
Dr .  Wolfe ,  if  he  is  at  all  interested  in  achieving  better  medical  service  instead 
of  headlines  that  serve  himself  and  no  one  else . 


J 


969 


APPENDIX  A 

Statements  of  Baron  Gosnell,  M  .D . 

There  is  an  apathy  of  the  medical  profession  and  a  lack  of  awareness 
about  the  importance  of  responding  to  people's  needs.     It  should  be  obvious 
from  the  distance  the  Chicago  women  travelled,  the  risk  they  assumed  and 
the  determination  they  had  to  do  whatever  they  had  to  do  personally, 
and  perhaps  dangerously,  to  avoid  an  unwanted  child,  that  it  would  have  been 
irresponsible  not  to  respond  to  these  women  with  whatever  resources 
we  could  muster.     The  fact  that  these  women  were  unable  to  terminate 
their  pregnancies  through  orthodox,   medical  instutitions .  is  a  condemnation 
of  the  medical  structure  where  medical  care  is  limited  to  acceptable, 
academic  centers  so  far  from  the  people  they  cannot  possibly  know  what 
the  real  needs  of  a  community  are. 

Health  care  is  much  more  than  lack  of  illness,   and  the  medical- 
legal  coverage  that  forbids  physicians  from  responding  to  people's 
needs  in  new  and  creative  ways  has  failed. 

As  to  the  super  coil  being  experimental ,  the  method  is  an  extremely 
old  one ,  it  has  been  a  known  abortifacient  for  centuries .  It  was  a  simple  matter 
of  knowing  that  soft  sterile  material  was  better  to  achieve  a  miscarriage 
than  hard,  rigid  material. 


970 


In  the  Some  week  tiiat  the  Guicago  women  travelled  to  Philadelphia, 
an  anesthetist  in  a  Philadelphia  hospital  turned  on  an  unconnected  machine 
and  killed  a  woman.     In  New  York  City,   three  women  had  hysterectomies 
that  week  after  complications  from  abortions.     A  women's  group  in  New 
York  was  unable  to  prevent  a  hospital  from  releasing  a  woman  with  a 
22  hematocrit. 

• 

Incidents  like  this,  I  am  sure,   occur  throughout  the  country 
but  go  unreported  because  the  medical  profession  protects  its  own  to 

the  detriment  of  patients. 

\ 

In  Philadelphia,  even  today,  at  the  hospital  of  the  University 

of  Pennsylvania,  free  abortions  are  given  to  the  first  10  women  who  call 

in  on  Monday  morning .   if  they  are'  registered  clinic  patients .     What 

happens  to  the  next  10  or  the  10  after  that,  or  the  ten  who  do  not 
'<  ■    » 

even  know  where  they  can  get  an  abortion?   Those  women  are  the  proper 
concern  of  those  who  care  about  providing  medical  service .  > 


} . 


971 


APPENDIX  B 

Second  Trimester  Terminations  Utilizing 

A  Specially  Designed  Intra  Uterine  Device 

A  Promising  Alternative  to  Amniocentesis 

Lee  D.  Newman.  M.D. 

San  Vicente  Hospital 

Los  Angeles.   California 

Abstract  For  Non-Traumatic 

Second  Trimester  Terminations  Utilizing 

A  Specially  Designed  Intra  Uterine  Device 

Thirty-two  second  trimester  pregnancies  were  terminated  on 
conscious  patients  utilizing  the  "Super  Coil",   developed  by  Harvey  Karman. 
This  two  stage  process  involves  the  insertion  of  one  or  more  coils  which  are 
removed  within  16  to  24  hours.     Cervical  dilation  was  not  required  for 
insertion,  but  five  patients  required  slight  dilation  and  six  required  a 
mild  analgesic  at  the  time  of  evacuation.     There  was  no  morbidity.     It  would 
appear  that  this  technique  can  be  safely  employed  by  nurse  practitioners 
and  paramedic  personnel. 
Introduction: 

Hysterotomy  and  amniocentesis,  the  most  common  methods  for 
terminating  second  trimester  pregnancies,  require  considerable  skill  and  are 
not  without  risk.     Consequently,  a  technique  which  is  simple  to  perform 


972 


and  wh^ch  woiiid  appear  to  subject  the  patient  to  less  risk  of  morbidity  deserves 
further  investigation. 

One  of  the  major  advantages  of  the  "Super  Coil"  over  "salting 

out",   aside  from  its  simplicity,  is  that  the  13  week  patient  need  not  wait 
until  her  16th  week  for  a  saline  infusion.     Other  advantages  include  the 
ability  to  predict   (and  schedule)   the  termination,  and  the  utilization  of 
a  treatment  room  instead  of  the  O.R.  with  its  innate  anxiety  provoking 
atmosphere.     The  Super  Coil  is  inserted  in  much  the  same  manner  as 
any  I.U.D.   and  can  be  removed  16  to  24  hours  later,   at  which  time  the  cervix 
will  be  soft  and  dilated.     If  the  uterine  contents  do  not  spontaneously  expel 
at  this  time,  they  may  be  easily  removed  with  ovum  type  forceps  or  suction 
curette . 

The  flat  plastic  strip  used  to  produce  the  coil  is  approximately 
40cm  in  length,  but  in  its  prepackaged  position  it  measures  only  2i  cm 
in  diameter.     After  insertion  the  coil  begins  to  slowly  unwind  and 
will  measure  from  5  cm  to  10  cm  in  diameter  upon  removal.     Nylon 
sutures  attached  to  the  tail  of  the  coil  facilitate  removal. 

Procedure: 

Thirty-six  patients  who  were  scheduled  for  amniocentesis  were  given 
the  option  of  switching  to  the  "Super  Coil"  procedure.     Thirty-one  elected 
to  do  so.  and  another  patient  was  added  to  the  study  after  two  attempts 


i 

I 

973 

at  saline  infusion  had  failed.     Each  oatient  received  routine  laboratory 
and  hospital  workups.     Ten  patients  were  treated  as  supervised  outpatients 
(i.e.  trained  volunteers  stayed  with  each  patient  at  all  times  until  she 
returned  to  the  hospital)  .     Insertion  usually  took  place  at  6pm  and  the 
removal  at  Sam  the  following  morning.     A  short  vaulted  speculum  exposed 
and  stabilized  the  cervix.     The  uterus  was  carefully  sounded  to  determine 
extra-ovular  cavities  which  could  serve  as  coil  deposits.      (No  set  number 
of  coils  is  required,  but  one  coil  is  generally  added  for  each  week  of 
gestation  beyond  twelve  weeks,  up  to  a  total  of  eight  coils.)     The  5mm 
inserting  tube  required  no  dilation,  but  where  stenopeic  symptoms  were 
suspected,  simulated  laminaria  plugs  were  inserted  to  guarantee  sufficient 
aperture.     Psychoprophylaxix  was  supplied  during  insertion  and  removal. 

Evacuation  was  uneventful.     In  each  case  a  blunt  curette 
or  6mm  Karman  cannula  was  used  to  check  the  uterine  wall.     One  unit 
of  methergine  was  administered  in  about  one  third  of  the  cases,  but 
each  patient  in  this  group  was  over  18  weeks  gestation. 

Patients  were  discharged  within  one  to  four  hours .     Each  patient 
was  seen  two  weeks  post  abortion  for  a  check  up. 

Results; 

Thirty-i-two  women  seeking  second  trimester  abortions  were 


974 


successfully  treated  by  the  "Super  Col!"  technique.     None  required 
pre-dilation .     A  few  requested  and  were  given  a  mild  anesthetic. 
In  four  cases  the  amniotic  sac  was  ruptured,  resulting  in  a  partial  loss 
"df-fluid  and  slight  leakage,  but  without  interrupting  the  normal  abortive 
process.     No  patient  experienced  complications,  but  five  were  given 
prophylactic  antibiotics  because  of  a  history  of  susceptibility  to  infection. 
Non-significant  bleeding  continued  in  some  cases  for  two  weeks.     Contraceptive 
I.U.D.s  were  inserted  in  eleven  patients  immediately  following  termination. 

Discussion: 

•  While  the  sample  in  this  study  is  relatively  small,  the  simplicity  of  the 
procedure  suggests  that  it  has  broad  application  in  many  areas.     The  training 
of  allied  health  personnel  in  this  technique  would  relieve  the  acute 
shortage  of  hospital  bed  space  and  the  physician  work  load.     It  would 
also  eliminate  the  cruel  waiting  period  imposed  on  women  not  fortunate 
enough  to  get  an  appointment  within  their  first  trimester  and  who  then  must 
wait,  sometimes  several  weeks,  until  a  saline  can  be  scheduled.     The  usual 
complications  would  also  appear  to  be  less  likely,  making  this  a  feasible 
procedure  for  licensed  clinics. 


975 

APPENDIX  C 

[From  Ob.  Gyn.  News,  Feb.  1,  1973] 
Saline  Abortion  Technique  Seen  as  "Less  Than  Ideal" 

New  Yobk — No  physician  should  be  using  saline  to  induce  abortion  unless  he 
has  experience  with  the  procedure,  is  aware  of  the  possible  complications,  and 
is  ready  to  deal  with  them,  four  speakers  emphasized  at  a  symposium  on  abortion 
held  by  the  New  York  Academy  of  Medicine's  section  on  obstetrics  and 
gynecology. 

They  defined  some  of  the  complications  and  unexpected  findings  associated 
with  abortion  and  cited  some  alternatives  to  the  saline  technique. 

Dr.  Morton  A.  Schiffer,  of  the  State  University  of  New  York  Downstate  Medi- 
cal Center  and  the  Jewish  Hospital,  Brooklyn,  pointed  out  that,  good  as  the 
abortion  record  has  been  in  New  York  City  from  the  health  department's  statisti- 
cal standpoint,  even  one  death  is  too  many  for  the  physician  performing  the 
operation,  and  all  attempts  should  be  made  to  see  that  none  occur. 

As  all  the  abortion-associated  deaths  reported  in  the  city  last  year  followed 
saline  infusion  or  hysterotomy  for  gestations  of  more  than  13  weeks,  it  would 
appear  that  the  techniques  being  used  are  "less  than  ideal,"  Dr.  Schiflfer  said. 

The  apparent  ease  of  the  saline  infusion  procedure  has  led  to  its  being  carried 
out  by  inexperienced  personnel  who  are  not  fully  familiar  with  the  technique  and 
in  institutions  that  are  not  fully  equipped  to  handle  the  complications,  he  said. 

A  physician  performing  an  abortion  should  be  ready  to  give  appropriate  anti- 
biotics if  they  are  needed.  He  should  be  ready  to  carry  out  curettage  and  should 
not  procrastinate  if  bleeding  occurs,  Dr.  Schiffer  advised. 

Furthermore,  proper  uterine  exploration,  if  indicated,  requires  general  anes- 
thesia. 

Reviewing  fatalities  that  have  been  reported  subsequent  to  saline-induced 
abortions,  the  physician  pointed  out  that  the  cause  of  death  has  not  been  sharply 
defined  in  all  cases  and  that,  in  most  instances,  death  has  been  delayed  rather 
than  immediate. 

It  appears  that  improper  selection  of  patients  may  have  been  responsible  for 
some  of  the  deaths,  such  as  those  that  have  occurred  in  known  asthmatics,  car- 
diacs, and  heroin  addicts.  In  these  patients,  death  has  been  attributed  to  cardiac 
arrest,  pulmonary  edema,  and  shock,  he  said. 

In  many  cases,  water  intoxication,  followed  by  convulsions,  has  been  the  sus- 
pected cause  of  death.  Patients  have  also  experienced  possible  amniotic  fiuid 
embolism  and  cerebral  damage,  possibly  from  fluid  overload. 

There  has  also  been  an  increased  incidence  of  complications,  especially  hemor- 
rhage, associated  with  the  trend  toward  increasing  use  of  oxytocin  to  shorten  the 
interval  between  infusion  and  abortion.  Dr.  Schiffer  reported. 

So  far,  there  have  been  no  reports  of  ruptured  uteri,  but  it  would  be  well  to 
study  further  the  use  of  oxytocin  for  this  purpose,  he  advised. 

There  is  an  inherent  risk  in  the  use  of  saUne,  and  there  is  a  need  to  find  less 
dangerous  drugs  than  oxytocin.  One  possibility  may  lie  in  the  prostaglandins,  he 
said. 

Dr.  Harold  Schulman,  of  Albert  Einstein  College  of  Medicine,  New  York,  said 
that  although  a  high  failure  rate  has  been  reported  by  others,  he  and  his  asso- 
ciates have  had  complete  success  using  prostaglandin  F2<»,  administered  intraamni- 
otically.  The  use  of  this  drug  requires  experience  with  monitoring  intrauterine 
pressures,  however,  and  the  patients  have  considerable  pain  and  require  large 
doses  of  analgesics,  he  acknowledged. 

Another  alternative  to  the  usual  method  of  sa'ine-induced  abortion  is  to  instill 
the  full  salt  load  of  40  g  and  remove  it  after  30  minutes,  by  which  time  the  woman 
will  have  absorbed  about  10  g.  This  method  has  been  successful  in  more  than  20 
cases,  Dr.  Schulman  reported. 

However,  saline  infusion  carried  out  projierly  is  virtually  without  risk  of 
death,  he  said. 

A  complication  that  has  caused  some  concern,  and  which  Dr.  Schiffer  also  dis- 
cussed, is  disseminated  intravascular  coagulation.  This  has  been  associated  with 
few  clinical  symptoms,  and  Dr.  Schulman  pointed  out  that  some  consumption 
coagulopathy  occurs  whenever  the  uterus  is  emptied,  even  during  normal  labor. 

With  saline  the  fibrinolytic  degradation  apparently  begins  earlier,  about  1 
hour  after  infusion.  It  may  be  simply  the  first  indication  of  uterine  contraction, 
or  it  could  represent  tissue  damage,  Dr.  Schulman  suggested. 


976 

Deflbrination  is  more  likely  to  occur  when  oxytocin  is  used.  Dr.  Schulman 
pointed  out  that,  although  it  is  the  physician's  obligation  to  terminate  the  pr^- 
nancy  if  he  is  doing  an  abortion,  he  does  not  have  to  do  so  at  a  specific  time. 

In  contrast  to  what  he  feels  is  the  low  risk  with  saline,  there  is  considerable 
risk  associated  with  either  hysterotomy  or  hysterectomy.  The  latter  should  never 
be  offered  for  abortion,  Dr.  Schulman  said. 

Any  operation  carries  the  risk  of  hemorrhage,  infection,  and  anesthesia  com- 
plications. 

Dr.  Schulman  also  commented  on  the  highly  favorable  results  that  are  being 
reported  with  what  has  been  called  "miniabortion,"  menstrual  extraction,  of 
menstrual  regulation. 

This  involves  simple  aspiration  throug'h  a  cannula  inserted  shortly  after  a 
missed  period,  when  the  woman  may  not  even  know  she  is  pregnant.  It  is  a  very 
exciting  advance,  and  it  can  be  done  very  easily  in  the  physician's  oflBce,  Dr.  Schul- 
man said. 

He  expressed  the  hope  that,  because  it  is  technically  an  abortion  and,  under  the 
city's  health  department  code,  has  to  be  performed  in  a  proper  facility,  the  code 
wou  d  be  changed. 

BEPLY  GIVEN 

(In  reply,  Joseph  A.  Cimino,  Commissioner  of  Health,  New  York,  who  also  spoke 
at  the  symposium,  said  that  his  department  is  presently  studying  the  procedure 
and  will  act  according  to  recommendations  from  its  advising  physicians. ) 

The  most  serious  abortion  complication,  no  matter  how  the  abortion  is  car- 
ried out,  is  uterine  perforation,  which  may  result  in  bleeding,  bowel  obstruction, 
and  shock.  Any  of  these  findings  are  indications  for  laparotomy,  said  Dr.  Myron 
Steinberg,  of  Mount  Sinai  School  of  Medicine  and  Park  East  Hospital,  New  York. 

The  latter  institution  has  performed  more  than  43,000  abortions  and  243 
laparotomies  in  the  past  2  years,  most  of  them  for  tubal  ligations.  Dr.  Steinberg 
said. 

Of  the  24  emergency  laparotomies  required,  two  were  associated  with  a  rup- 
tured corpus  luteum  cyst.  In  many  of  those  that  were  due  to  abortion,  the  per- 
foration had  not  been  suspected  before  bleeding  or  impending  shock  occurred, 
he  said. 

Vital  signs  of  abortion  patients  should  be  checked  at  10-minute  intervals,  and 
a  rise  in  blood  pressure,  drop  in  hematocrit,  abdominal  tenderness,  shoulder  pain, 
or  shortness  of  breath  should  be  considered  indications  for  explorative  surgery, 
he  advised. 

In  several  cases  uterine  perforations  have  healed  themselves,  but  Dr.  Stein- 
berg pointed  out  that  most  of  the  patients  at  Park  East  Hospital  are  young, 
healthy,  middle-class  women  who  could  be  expected  to  have  good  healing 
capability. 

EMERGENCY  LAPAROTOMY 

This  factor,  as  well  as  the  experience  of  the  staff  and  the  availability  of  a 
general  surgeon  for  bowel  surgery,  has  accounted  for  the  rapid  and  complete 
recovery  of  all  patients  who  required  emergency  laparotomy,  even  when  the 
initial  postoperative  course  was  stormy.  Dr.  Steinberg  said. 

He  added  that  subsequent  pregnancies  in  a  woman  who  has  had  a  perforated 
uterus  should  be  delivered  by  cesarean. 


977 


Behavioral  Research  Center 
Federal  Bureau  of  Prisons 
Butner,  North  Carolina 

May  24,  1972 

The  Behavioral  Research  Center  will  be  a  unique  facility  in  the 
Federal  correctional  system,  specializing  in  long-term  research  on 
the  treatment  and  management  of  various  types  of  offenders.  The 
Center  will  study  and  treat  selected  subgroups  of  offenders  in  an 
attempt  to  devise  effective  treatment  programs  which  can  be  adopted 
by  other  correctional  facilities. 

The  "behavior  modification"  program,  housing  about  190  persons, 
will  attenyDt_to_dev.e.Lop..programs  for  subgroups  of~ofTenders.,_such.  as 
aTcofioTTc  felons,  minority  groups,  dverl y  passive  f 61 1  ower  tyi)es,  and 
various  other  groups.  These  inmates  will  be  Vt  Butner  for  a  period  of 
intensive  study  and  treatment  in  an  effort  to  determine  what  kind  of 
correctional  program  is  effective  with  each  type  of  offender.  A 
system  for  monitoring  results  during  the  treatment  period  will  be 
devised  and  the  evaluations  of  these  studies  will  be  published. 

A  "mental  health"  program  will  care  for  a  population  of  about  35 
young  men,  35  women,  and  60  adult  men  who  are  in  the  acute  phase  of 
mental  disturbance.  The  objective  of  the  research  program  will  be  to 
develop  and  implement  Intensive  treatment  approaches  for  mentally 
disturbed  patients  who  constitute  a  management  problem.  The  treatment 
effort  will  attempt  to  stabilize  these  special  cases  so  they  can  be 
returned  as  quickly  as  possible  to  the  sending  institution  to  resume 
their  correctional  treatment. 

Various  treatment  approaches  will  be  used  in  the  semi -autonomous 
housing  units  including  group  therapy,  individual  counseling,  specialized 
education,  vocational  programs,  social  services  and  leisure-time  activities. 
However,  shared  activities  will  be  provided  in  a  central  area-small  chapel, 
canteen,  dining  hall,  indoor  and  outdoor  recreation,  auditorium  and  clinic. 
This  "Community  Green"  will  resemble  a  town  center  where  residents  and 
visitors  can  associate  in  an  atmosphere  as  normalized  as  possible. 

The  location  of  the  Center  makes  possible  a  close  working  relation- 
ship with  the  medical  schools  and  universities  in  the  Raleigh-Durham- 
Chapel  Hill  "Research  Triangle"  area.  Staff  members  of  these  organizations, 
as  well  as  representatives  of  the  National  Institute  of  Mental  Health,  the 
Department  of  Health,  Education,  and  Welfare,  and  the  National  and  North 
Carolina  Advisory  Panels  to  the  Bureau  of  Prisons  have  assisted  the  Bureau 
planning  staff  In  developing  the  programs  and  architectural  design  for 
the  facility. 


978 


Instead  of  a  traditional  institution,  the  facility  will  have  a 
more  psychologically  pleasing  character,  designed  to  be  adaptable  to 
changing  research  procedures.  Rather  than  guard  towers,  underground 
electronic  detection  systems  together  with  a  mobile  vehicular  patrol  will 
be  used  for  more  effective  perimeter  security.  Special  windows  of  a 
special  plastic  and  glass  laminate  with  a  built  in  alarm  will  furnish 
better  and  more  economical  security  as  well  as  providing  a  better  thera- 
peutic environment. 

The  architectural  firm  is  Middleton,  Wilkerson,  McMillan,  of 
Charlotte,  North  Carolina,  who  will  also  provide  construction  management 
services  for  the  project. 

Statistics 

Capacity:     Mental  Health 

38  Youth  -  Male    , 

64  Adult  -  Male 

38  Female         > 

Behavior  Modification 

200 
Maintenance  Cadre 

40 
Infirmary 

"335"  TOTAL  BEDS 


Square  Footage: 
Area  Inside  Fence: 
Construction  Start: 
Construction  Finish: 


235,000 
42  Acres 
June  1972 
Winter  1973-4 


)   . 


,  » 


i  *:        0 


979 


I^coob«r  *1?72 


Project  :jiiC:rt  (special  trsatsei:!  sM  rshjutiXlt&tlio  iraiAijci£)t  ^ 


4  F^^^ral  IrXsoit^r  CwailtliHR  ■tat«::ient  rt^arcilr;;  Vro  ^:*3»  ta;  a  ti^drt  cX 
•Juetict'a  U9W  e^orl£>3r.t  In  ddnucaclftft^lon  of  lie  c^  tivos* 


980 

iBfofMUfla  eoi8urc«»t  (u0»d  la  foxml&tioe  of  thl«  n^ori) 


!•    S«  5«  Bureaa  of  irrleccs  Cip«r«tloDe  KoeorsnlBa  f  7300«12d« 
<lAWa  October  2S»  J?72|  t»ruci  uiidsr  ci>;x>awrt  cf  i-orsAa 
A*  Ci^rlaoa^  X^irecicTy  ii«s»^urt&k  cf  ^ccr&« 

8*    V*  5«  Bur«<a  cf  ?rlKci:ia  weekly  s^iirdl«tt«r  atfcrtiosae^t  ("Ijoroaa 
uwais^ta")  for  Project  SiiJ<Xt  Coiob«r  *  1972* 

3*    frlTCUM*  tcfttiariv^  (a  <ir*et  idtnofta)  to  Project  ^1SX*« 

[)•    Xr«0iscz*ii>t  cf  u*6*  curo^iu  of  >rido:^e*  iU^slnar  on  Ctoreed  3«* 
«k4  it«  Joorsval  if  .^«^ftX  'i^T^j*$  fi>Iua«  busbar  2»  Cctcber' 

5>»    Fe^ral  Frl»cnor  Coulitlcn  retort  to  tl e  JnlVad  LatlccB*  oioei<*l 
•to  i:.coaCkSdc  Ccuccil^  (laved  JiUy  5U;*X972« 

6.    !}»£•  CwoeUtttUott  a£d  3111  of  PJi^hU* 

7*    Gcoava  CooTcotio;^  Aocorda  Batvaon  Clvilisad  Batioua* 

tm    Xaturr.«X  c&cdiilccia  at  iuurloQ«  I31tnclg»  u*8»  Sodaral  yrkan  In 
tho  laT.Urr  r  alf  cf  1>72  -  incI-aiTi:  cf  U.e  e^atix.^  pc-l  cf  ia- 
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CofUft  af  ItasiB  nusber  1,  2,  arji  $  aav  ba  obt&lr«d  frozi  attcmej 
f:i<j>-a€l  tii^ittcit  aX  ti.9  -^ttiotal  Im^^trn  autld  Offices  at  kl  £aet 
Taa  fjarcA^  Ckleaj,o«  IXllraia  •  for  t^ja  east  of  chpllcaVLosu 


1 


981 


VlUdA  Ills*  «•»•  a-r««tt  ^  prieci>«  Ui  Aax^OLSt  and  ?^t«»ber  of  1^72  M.9  9tA£« 
vfiS  ««t  foT  c&^^ulevi^y  t=jedlc&l  (^.e&tal  «cioii©«fi)  itfs? ©riser. t&tlvC  Hs-cg  adaJt 
off«i*iirf  vtWiiu  tiiAt  bur«HB.*«  ?ri«»n  ha^itzl  ««ttir«3  ai  its  carrer^t  locitloa 
in  Sprin^fiald^  Ki««carl»     Hi*  e^qpcjriwwits  y©ii*^  ccj:i«idctoa  cf  «r«Ac  un<ior  th« 
sospieee  of  the  u.s.  \xoosa  of  i;rU©iiS»  y«nt«l  Lwdih  S^rrtce  <5e?.«rt5»at|  ifttdi 
ia  in  «^«xust  of  t&6l^*S*  Pvttllo  Eaaltiit  2«rvlc*» 

tt»  teiTfiCBi  efprlsone*  eperati(»&&  B8Korstui;<ua  cutJijnlzsg  thla  vftcture  calls  for 
prisocittrs  ••lected  for  thc&e  qaasl^aedloal  fAperlcaects  to  b*  taken  fron  their 
bona  araaa  find  z«locat<d  eiwhta  a  8agres«t«4  uclt  at  .'^riccriald  liodical  Center 
For  r«d«r«l  ?ric*r«r»« 

46ebaTi«r&l  peyO^oXo^is^  troa  Carbosdi2lo>  Xllixiola  (adjaceot  to  Clarion  federal 
pri^n)  cased  Alport  Sct^eJcaiJi^ch  1«  in  chared  ct  tl.is  unit  Cae  stated  ir<  t>:d 
««9*  boraaa  d  f  rlsctia  9e&!cljr  xie^'^lettar  *:)ure;iu  2ii,.;hIi.^ta"of  October  •  1972 
th£.t  a£V«rtl«a>B  tt9  pre^aeia  c^ealAii  a;:d  solicits  -$.i«tirji  trxi^B.  coilor  prisui 
adBir;i«tra>t«r£r}»    £o  ir&a  trsdc^d  Tor  Ida  <j&ti9a  at  Coatharn  Illinois  vnivar^itri 
lAXid^f,  flarioB  feddral  priecc*©  b5:-«vi«»ral  ^tocifitaUcn  -jnlt  (kcojai  locally  aa 
^h«  4ak«l8pi^i  iociet/),  ^<^&t  en  Illinois  Stata  I's^tisfOB  ^ac^rity  Icstlt;iticii* 
pre^mcii^dy  an<5ar  U^  e;c»^suXiiTe  uirectlen  of  tr»  >';artix:  ^•CrciisB',  u«e.»  buraaa 
of  pri«c42a'  pcycblatrlst  Usl  ckargo  of  di^valopins  bc^>avicral  0cdifioatlo&  pro* 
grasa  aisd  entitlo<i  «»V:ard£ii-.*or  t^.e  rut:.«r,  l-ort*".  Carolina  fcwsral  priecn* 

PrisoJiors  aie  e<r;teoeed  tc  sesrei'&tion  yrithii*  Ua  3iA  S  unit  for  a  uir.irus;^^  of 
•ii:;htaan  (lb)  isontha  *  ieolely  ':;Qr  a;iQi^lrtr&UvQ  roGla^sificatloit  one  without 
a  ^aarizi£j  sotificaULon  or  oUior  al^iLe^te  &f  due  proceaa* 
»  Cperationo  Ki:3t,rardiMi  f  7^*128  i^f  tl.«  u.e*  buraau  of  priecna,  dated  10-25-72* 


93-999  O  -  73  -  pt.  3  --  13 


982 


XX  is  nported  to  a«  (fay  iprloon^r  t.<«£Us:££/)  Vr,A   sfxatz  ^^  taclico  ased  vi^iJi 
•tiaall  t»  lattice  etatea  of  j^pat^^tlv  sngg«etlbiXi^f  etrici  punl*h.ier*t/i^«MJrd 

.u^a^  ,^^^  to  «...  «.  ...^o..  ».mt,  .o-».^^it,  ru^,«  ^  , 

^stroy  tb«  ci^haity  and  will  to  red!  ft    tct«l  otl.ttr«<k»t«nU^lffa  )7  px'iKS« 
•tthoritlotf  •  wid  tti:  cot^l^to  3«^  of  t&ctC'Va  cutXia«d  in  pAv^es  iAsOp  U:na«« 
tf^d  foor  of  Xt9  Kedoral  Frls^itor  CosHtoa  r«K.ort  to  the  United  &&tlo&«0  <l«.(0d 
Julj  5thf  15^721  a&on^  uhict  «res 

!•    Fhjsicel  reaoval  of  prisuaer^  tc  an  ore*  •officienUy  isolated 
to  effectively  brt>4Jc  or  aerlo&slj  weateii  oXoee  eaotit^ael  ties  to  fasil/,  fH^enda/, 
•s4  cc;«r..^it7  f  orewce* 

2«    Ue«  of  ocK^rettve  frleocera  ae  Isedert* 

J*    liraati&g  thoee  vho  are  idlllng  to  eollaborate  In  for  9tore 
lenient  waye  than  thoee  vho  arc  tot. 

It*    Puniebceri^  fcr  vcco&;:-eratlTa  aitita<le8* 

5«    Xotal  preventicx^  of  eontaot  vith  sryoTi^  si(tc»syT^aM:9ti9  to  Ue 
&eU4»d  of  treat*2^nt  ar.d  refjisieT;  of  tie  captltes* 

6.     Cjatesa^lc  i?lt2;hoJdlii2  of  tK&il« 

7»    WoriO&g  to  bttild  a  s»^o«^*^i^nTictlca  aa^n*  Xi»  c«g?tiveB  that 
tJi^  ^are  been  ac;iC.ilcj:ad  Xty  and  totally  inclat^d  f«>a  U;«ir  accial«-oroor  and 
the  f zxtectlcQ  of  its  laea* 

3*    risor;^«::iaatlca  of  all  volitlMial  ^ou^-statuiarUe  tnoo^  tt» 
prlaocere* 

$•    Vn6tandXixi%  of  all  mxti^lcsial  KKjpporta  prleoners  attespt  to 
UuHd  Ir.to  tf^oir  o&vlror^icnt* 

2/ 


983 


IC,    rr«v«i:U.:g;  j-rlsaierf!  fros  writir^g  ho^c,  or  to  frlendo  in  t::oir 
haaa  CwasaiEities,  cr  alrcwtxre,  i^jardic^  the  ccx:*tiltlGiis  of  their  ccRflc^ajent, 

!!•    Ferr^ittii:?;  acw^sa  to  no  bcckc,  periodicalc,  or  otLer  r-'ablicatiwie* 
12»    tyatfeKnitc  crcdir.^  ot  will-fci^er,  ccEtrd  cf  aentftuiccal  C£g;Aclt» 
le&9  «ifS  eswjtioi-Rl  b  J^Kf.     CAa  c^r  £*  d«t^r:Ji-«d,  each  of  tLt  factors  ocitllrsed 
is  U.«  aboT9  rwri'.icKed  report  to  V-a  u,::.  are  present  in  riA'^I'a  op«rAtioQ|  with 
ti<>  r.^lfc-w-cTt'T  Sicdl'ici.Uor-  cf  fell  ci.Mror.vutsl  ti:cc.:p atitjilltiT  b^ift^  accer.tod 
\i»  ee^re^-tic**  (tot&l),  uae  cf  drtga  and  ct^er  factors  •  ccnstitstis^  •&  Intwa*-' 
ifieatics  of  lnvidiou6ae«s  in  all  respects  to  tto  tftcticd  uAod  «lc08rt«r««) 

'    3Tx  T'f  trictlEG  to  data  inciu«»  oz»  tot  si  eucc«e8  in  tbe  fbra  «f  a  »iici4«  • 
I     oceaitiod  Cw5:«  kcure  tftor  the  prlec&er  va'J  r.ctiflad  tr.-ct  ba  van  to  t>e  ?:ioved 
to  tro  SlA^:T  utlt  froa  within  the  '-Cttlcal  Cer.tsr'e  lic^^-ital  facility, 

lb«  a«i5«  t>urep-tt  of  pricono*  op^rat-ioa  5i«su;r«  Ovia  for  f  reject  HAl^t  Is  cited  to 
09  eartcellttd  ^ffcetire  Oetobor  3I,  X973;  ^ich  Is  TpTessiSi^id  to  bo  <^2e  to  U^e 
Butacr»  Korth  CarollJta  b'.havicrrj  r.o-'ificr.Licv.  pri^.n  beif.r*  slated  U>  o;fca  at 
thai  pol£t  ic  ti£6  for  ouch  c^.o'^&Ucns* 

iho  cc';;jecv..r*  of  ;n^^;4^e^8  Of  thfe  Tocior&l  i:*rievn«r  Coalition^  «t  present^  io 

tl.at  project  rTA"t  i»  (icgtcrwd  (is  part)  to  toct  ti^o  f«»ssltility  of  diTostiiH; 

0»l«etcd  %letl?>ff  cf  all  ri^^ta  uikdsr  Conctltutionsl  luid  Pviblle  Law  vift  the 

proceea  cf  artitrarilly  lAJ>slln<^  tt«a  undor  tr^  gsr.oric  tors*.  •Sent&lly  disordered 

(distarbttd)  Offendftrs**;  vMch  tlo  Circe tcr  cf  tlio  a«s*  Wraaa  of  f  ricoiia  deficoil 

(in  ti-q  al^ve  citsd  opcri-ticns  a&.'«r*nckus}  to  zaasa  "  iiOt  psychotic,  md,  in  toriSS 

of  rersocaaity  o^uirACt^rieticn,  chall  be  a::rcssiT«  (atafefi.i6d),'*'J3«*rJL|.ulati-vo  (\Ui- 

(*  •  friccror  C;  arltjc  Alfar^  avta'^pt^d  suicide  cr.  Jur^e  2-;,  r>72  and  expire  tte 
fol2&vti~<{  3sornir;«  6r«3  was  datiled  ysrole  ch  ti:c  ai^o  i*7  cf  ocir.^  £»l«ct£d  for 

o'^JH^  J>^?.i8  cJcati:.  and  detaila  i.^  b*  obtainsa  frw^a  t£.€*/fricc  uf  'J.C*  t>«iiator 


'»o. 


, .  ^ 


V 


984 


C>;&ract«rlse<wlo&  of  «  prlsctier  lifr  a  Warden  ot  a  f«d«r«I  Ir^stitutigtt  «dt.Mn  t^« 

a  distant  &at2:6rlvj  (kci2>m  £js  tlo  "Coordlt.^tcr  of  f^«u;;.al  Health  -S«nric«i})  Is 
r^$9Tdmd  tc  b«  a^sc^nata  proec^ril  dao  proc«s«  (frca  a&  J^c^sl^iatratlTo  vl^-i^Qlnt)  i 
to  bejin  eubjeoiic-j  tl>oes  prisoaera  lifaled  in  t:>ia  stancer  to  tta  bricflj  cat* 
lined  treateamt  pra&ticec  en  tha  pracodixig  P&^«    Ad  sira  of  tit 000  procacScrea 
boir.g  "  tl;dr^.7  gnd.  1  gltisu^ta  trdstseat  cX  sic^es^*  is  aou^ht  to  b«  induced 
into  XiiXe  pro^'^ot  bgr  «79cci&ticn  of  Vta  progra^.  %iU;  sen  b^arin^  sedicallor 

ace«$^;M<i  titles  ar.d  t^>e  ur.ii  being  bidden  vithic  a  prieott*S;o^ii«l» 

-^  \  ■    ' 

It  ahOAld  be  noted  b^  thoae  inTeotigati&s  this  u*«»  bsxttaa  cf  prison  cperdticn 
tbat  the  entirety  of  the  direotivee  iasuici^  trcn  the  Wat^lngtozip  r«3«  offiece 
of  t;«i  barasB*    rei«vive  to  it  etai>e  *nd  accent,  bott;  explicitly  and  implicitly, 
that  tbe  *treatsect»ia  aioed  at  Ccatrol  as  a  ^al  t&at  i?  pnpoTlf  an  erea  of 
nedieal  praetiee,  and  th*t  enforced  ad^uetne-.t  to  e  pric-oti-reni^'^^n's  Qt.ss.c.crd9 
is  stated  to  be  tho    "reicabilitatiTe"  goal  &i:sed  at  ria  tfcia  eaterl^frcc.    At  ns 
po'.Rt  in  it3  pixjceAusal  cutline  does  tra  trcinis*  ar.i  rfei.ai*ilitatiua  alluiled  to 
collate  to  ttccifilly  relt^sd  ^oalej  tsit  correlatienc  to  ir.stltutior>Al  rsana^esant 
aiiss  are  cited  qaiti»  op«iiIy««*« 

It  is  as.vir^ti  by  tre  ?e*5r<il  Frisocer  Coalixfcnc  tLat  ea  attospt  is  boic^  xuida 
vita  Project  STaSX  to  eatablifh  idsdriatretlYe  Procedurea  tJ^atiriU  do  aervlce 
ia  desi^fcatiKii  priecwars  to  aatnar,  Tcrth  Carolina,  as  subjects  for  bai^arioraX 
Kodificatioc  Bxr-erisicTits  by  it*s  Vard«ii  and  fcia  ctaff  at  the  does  of  1?73»    Ve 
ea&  ooly  asaiae  that  tiiia  «s;piiee  to  U>e  criteria  for  aeloctios  and  resaarch  foslj 


y 


985 


aa  vsllj  i»  respect  U>  3utser* 


It  l»  tor-fc^m  Ctii  prl6c»i;<r  twtlscay)  that  four  tiers  <jf  ccdla  co^risa  tb.© 
SXJii^  Wilt  J  axui  ^At  A&.  ^iMris-z  therw  &r«  &a  silked  to  strip  •c«ll2  on  tha 
botUA  tier  of  eella  «>  )£ier«  ih«  ej^erisaenteb^e^in  «iU:  iGelatiozi  srd  ser^ccrj* 
derivation  «lo&|^  with  a&iaaliatle  X«7alo  of  treataant  lo  ra^.ord  to  ccnditioiia 
of  eu&flnaaia^it«    Lc^lI^^s^  srlre  fe^ca  ao^rarataa  this  nalt  froa  tta  $i&lr*^C3pal«tioa 
af  tiia  priew&»)>o^ltal  and  friacr.era  rela  to  that  it  la  aa  of f ar.a«  paBiah^^le  t^ 
belTig  takac  to  S^ringflald*«  hola  to  ba  cau^^t  falling  at  or  Attai:ptinstc  talk 
t&  prla;;>£:«r9  loti^ed  is  hlkul  (iujri.>(;  thair  axarciaa  ^«rioda  1&  i^air  faiwad«lo 
aai^ouxid*    Friscjiara  vitbia  tLa  xicXt  ara  kxicum  to  b«  belzx^srabjectad  to  coc^alaor? 
<^s&*ii^«  ^^  or^ka^tm  variitiaa*    It  la  kaovn  tiiat  &cat  of  ti^e  Tlctlria  in  U.ia 
ttiiit  as  cf  ati^!>;^T5Abar  hA,i  >^ari&c  fadaral  pxistta  aa  tif    e^tadir.:}  lusiiiuiivn  in 
thair  pj&.ca.^xit  vithiu  U.0  fxiaoa  at  ^rleiciflald* 

SlgniflcGnt  facVore  ti  at  ajpcsr  en  exi^lr  aw.cn  ar:d  ijcnoidorziiioc  of  ^tMii'  as 
prsaoj.tly  fcutdsd  vlthln^  Uo  c.s,  oureau  cf  irtftosa  <k>cusciita    acd  coKaunal* 
4ii*tw->'  (rAi:v/r-.  priev2;eri;)   ar«i 

1.    Prieonera  ara  relajatati  to  tLa  ai^va  liated  tonUitiec^a  of  ccifine- 
aant  i^  au  Ad-aiiiiatrAtiva  lali«li^,  procasa  in  «i;lcb  U-ey  ara  nut  actlf  led>  ara 
afforcad  t*j  frocadursil  a^irerearj  procaas  to  jltif^nd  tr^;isalTes>  and  are  not  jg^p* 
ri6«4  cf  t;,«  fact  liist  ti.ey  ara  to  ba  iaciated  in  sroas  cwKlitici:a  of  psycho- 
piiyaieal  duraae  and  issi.ijuiited  by  i  rvf e;:"^iwnal«  at  pjsjchtc-aseaiilt  and  coercion 
tbabnlQuaa  for  a  cililaaa  of  one  atid  a  hsilf  yaara* 

2*    Priffuiera  Juiaa  labeled  are  taSten  froa  their  feoiae  inetitatic&a 
to  tiiia  Cdiitral  Iccitlcn  vlthlii  tta  aura  «f  a  prisoa  for  tb^i  2*ia7:tally-d4ran^tad 
(thc-ugli  it  la  eilpulalod  tbat  they  aro  rot  to  b«  dorarr^tjd  prior  t«  arrivisl  ttare) 


986 


to  l€clat«  thes  fr-'S  -dlrc^at.  ecr.tect  with  U.cii*  eci5r=A,r,lti«»j  cc^rt*,  jTrisr-da  kz^ 
f&Ril/  tci-rb^r-jf  •  «r^  rilveet  U.<?«  thereby  of  4ll  fcuraAtl'»»  ocuv-iSity  ?rot«ctl«rn« 
a^siost  »6i«;ur«  of  ha:.tai:tf  as?  eubj^c^s  Sat  Ksdical  ttiGpariaer.ta  sl£«d  lit  ca«ircl 
«nd  affective  c^jfts-lr  aacn  of  t/elr  pa^acnalitlej  by  i:4Ji«;j«n«r.t  oi  ior^i^d  citii- 

3*    TI^Ie  i;T^,iTt»f  md  thoso  lik«  it  8bhr<iilftil  tor  l£^ltts^:Atati^i  i& 
the  i»ar  future,  ar«  via^l^ed  to  tp«rAto  uzit^  ti:«  <air&  ©f  *tr«^tlri^t«  patlact* 
^at^«r  tiharx  •t.unifiiiing  aii<!  ccatiolliRi;  th*  prleontr"!  txid  ttms  96CSk*  trariitivxal 
C«a3titutic£«l  BAfv^uards  ^«ln»t  »5a  of  qyatwBAtic  tocUdqa«s  &f  aiusit*  tr»ftt*» 
BttDif  cxo«pt  to  qu.6ll  «  riot  or  otj  «r  daf'>4^€rd\^  prltson  Uietar^itfic** 

!&•    tli»  StfiilT  JhrO'jrsa  la  «  &A&r  cl&s«lo  «x«sp}e  of  tew  tl.«  u.s*  bar««& 
of  prlfivus  is  6«okixi4<  to  ift(;l<Mfi«fit  a'Tt^rerllcial  Boiilioation  «f  ln<tituticnAll;&ed 
Tlcle&ca  acdcr  th*  c^wifift  of  •Yenal  t  iifonj'  i>7  ^allstiAj  car^ii.ali/  Oi^viojeJ  f  ecyk- 
i&triftto  &j'd  p6jc:olO(iialr«  to  fusWr  ^ria^o  violc&co  ucoAr  the*  t«cu^ii;£  of  Xh«r4>* 
outically  Crl<irted  Tx%&tttcnt  Wid  vltt  dollbemte^jr  tcl^ua  oUaflioo^  to  nralclAg 
aod  «^«uhahilitswlor.," 

5*    A  Clasa  cf  Tcrscsn  la  boirz  ercated  by  tfortaueratic  ottlLcty  foster- 
«*  without  |-r<^vi8i«ai8  for  Xit'JLf Ictttoa  cr  roviev  of  ti:«  ai2siii;i0tr*tiTe  ^ocese 
U6«d,  ufor.  >r;  v.«  aeiiically  ur-^-rcTSfi  :s«t];cds  cf  scTital  r«orlfint»tioa  «••  Iwtnj 
«gcd    ic  «icr«rirc!t.tsl  faehloa  ->  a»t  by  tir.-o  eae*  ccrractlon^  fi-tar^c  ti^^  cam 
8ou/rht  Btesdfaftly  to  KJdr.tain,  In  t?,«  feee  cf  all  reason  to  Vo  cwitrary,  <ttt* 
sttoifii  and  provaaly  fatllo  tec,inirjsiiS6  arid  BVani^Tda  of  tr«aV-««it  of  adult  cf roniiertaf. 

6»    TLa  u,.r»  biireaa  ctf  prlroua  cpcrALloce  »»6ff<»ra"d«Atia  md  diroctlvaa 
lfi«a«d  In  isjard  to  Vro  ClAFl  ?r&.:^rA?k  opoiilj  (aa'i  canlacAll;^)  insist  tfcat  t^o 
intent  of  U;l«  prograai  la  to  get  priacciere  to  eUjuat  to  yrlaap  r^tLar  tUc  to 
i«ooi«ty* 


C/ 


987 


7/     ST.*RI  Progx^tt  -  D"«c«*aj«r   1972   - 

7»     Thft  /A*Ttor»  of  th0  progx«£;»  lo  zeff^t^tct  to  cla*»tiric?\tion  of 
ha«aQ9  iox  coa;^4l»^x/  pAxticipxtloft  in  njedlCAl  «3Q>Qriss«nt»»  violate  cl«Arlj> 
•tftte<t  »ie>zl<i  Court  lA«t«  aiKMit  e^wKliticvm  in  tvhich  ft  civifl7;e<1  Q9V9rfu>«nt 
can  «AyAu«  in  cuch  «  wv^y  am  to'constitute  c<v%Etissi -^a  And  crvtJtpirdcy  t^ 
eowRit  cjimt*  agaifMit  bu«L^nity«     Th«i»«  c<yia^zLne  yiolA.tion«  xn  ovnaxy  re9]^ct 
•iailax  to  thosci  chaXv^  A<^i*i3t  th«  p«opl«  oX  ^Jiczt^ny  At  the  Qxmcliu^ion 
of  *»rW   «Ar  XX  daring  th«  H;ir*fll>*r3  Trials. 

it*     «^  convidex  ths  eftablitthMent  of  this  prv>Ject  anU  fl«nt«nclng 
of  victi?t«  t>  it  tc*  t*m  a  tlix^ct  a.^  /open  ciocIdXAti'xi  oif  MorAl  Atid  ettilcAl 
bAnkxuptc/  by  tha  il«S.  t:e^^rtA(j(nt  of  Judtice,   it!«  tar«fr<\a  ot  (arlsoiis^  And 
tb«  :i«s«  Public  K«,\lth  Uezyico  aath'.trititts  affiXlAted  <d.th  the  v«ntuztf« 

Altl»ou{^  thi»  fttAt^naent  i«  not  tim  lASt  «och  uttora<)C<ii  on  t^>e  Aabj^ct  by 

Xe<UltAl  |>yisoQ0rs»  it  gaa  bit  c>->nGlude<l  vtitb  tho  follov^itHj  xyiiv-^r VAliou*  And 

coi»clu&ior}s  f-.>r   the  pt^aenti 

To  oar  iiAy  of  think! ivj  th«r«  Atm  ttto  c<vrt<:titions  that  caq  d««troy  trm  |^ric 

of  «.  »ociAX*H>rv;«r  ;>A9t  Mf»i«2in^  if  a11ou«<.1  to  p«x«i«t* 

Uqa  •  is  to  ft&nctioo  ox  AlloM  a  jidxsotif  ox  gx«>\sp  of  ^>ar»ari«f  ttithin  ^ovk?rn* 

&oat  to  plAc«  thvi.fi«l/»3«  bwyorvJ  t««  piai/^tntiv*  r«AcU  of  tiwi  ^Ati •:>«•»  !&«« 

•pd  Ccn&titutioviAX  x«'^ulxeiMsnts« 

Tiro  «  is  to  :»Anction  or  aXXo^  a  pcxfon^   ox  ^^xoup  of  »>«r9>oa«t  to  birt  <i«;U>v6c«i 

by  gov«xn««nt  in  viol&tiriti  oii  Co.tJitltutiotial  r^  {aixAn^nta  to  tlia  ;^>oint  v^rhcra 

thoy  pas*  b«yoad  xiui  pzotecti^«  reach  of  tha  If.vr  and  th<s  t^Ati^ti's  Cor)i£tiuti->a« 

At  pr«sent  o^Jth  conditions  «xist  vrlthin  this  Nation  by  (^vertv»^nt<\I  «^i<:t» 
•anction*   and  ^'U'orctjj^-mt   — -  in  s<.^cr«t •.•••••• 

XbQ&e  Conditions  hAV«)  provr«»>«d  to  th«  point  M^Mtxd  tho^«  acting  Ix^yoiui 


988 


1 


pf«veatlv«  xeACh  oi  la»  (usMtez  color  <tf  !•«)  ^V9  coa«piz«4  to  cxe«t«t  by 
deciaXAtioa*  a  Class  e»f  pezsons  iM/^mtl  pcotectlv*  r«*ch  of  Law»  la  oxw«x  t«  i 
jutttiry  sutii  CK>4usit  acts  upon  th«lx  Rinda  Acui  cox|>oxal  pfts»<>a«  th«t  h«v* 
>tn^.v«z9Ally  k««n  diri^l&x»d  CziiM*  A^inftt  HvuMQii/vhen  p«zpat£At«d  by  GowcaN 
&«ntft  in  th«  r«cant  history  g£  v*oxXd  •v»nt«« 


T^^i  tr»«st  iKKiloAtor  a/  aoral  «ad  «thieal  b&akriiiftcy  to  wnlch  ««  c*m  polat 
*t  tbi«  ti««  i«  th»t  th«  individual  !:«  ao««m4«at  (Sdlzvctar  of  tha  a.g«  bwM 
of  pxi«oi-ui»  rfox^staa  ^  CAct«on)  yho  li«»  si&n(e<»  r.h«  £»Xr',;;X  £i«A»axa»  into  | 

ACUiiii«trAtlv«  ox4«r«  Is  xuam  Xh»  Uait^ct  3tat«a  of  A«axica's  <t«l4*^t«9  via 
Pxe»ld««itial  Appolot«$utft  to  th«  Urtltitd  Natlofia*  tiooi*!  Ait<t  4icom«ie  Co^mcili 
wh«ztt  ^e  Aiivoc^tciji  that  thAt  A(xly'«  f^tantlard  lU.ui»»i»  Bu.l«9  i<^t  Tt^e  Xx«Attt«ftt 
of  off«Qd9X«  b«  folloMed  by  civ^ilxni  a«tionJi  axourtd  thA  Nvisltlt  *rithout«  oJ 
coax««  xeveAlinQ  th«t  c^e.thft  to  vhlch  cxI^^kiaI  Jvi,Xlce  h&»  pl«tAi/e<S  vtlthin  Vm 
a*s*  bas4»ia  of  pxis<cmt»t  aricj  ««hllct  clai&ilng  public^lly  *(icl  In  print  thAt  ttMK 
StandAxdA  «r«  xi^ixoviaXy  JMSh4»xea  to  ««j  tbin  th9  ioatit^tintui  tinfiex  hi»  dlrod^ 
loo.  "  ^^     '      -'^■-  —  '^  •■.::;:•  :■         ^ 


I 

':3 


)«•  esncltidtf  that  till  fedas&l  pxieoti«x«»  both  ip»sd»«nt  atkI  fatar«»  hAVo  bo«o 
€9%f4tzf^ii  fxoT*  All  v«rfttiy4»   ui'  pxotectlon  inhexont  «rt«i  ctaliKl  withia/  th«  iJ 
Cos)«titutiv:»o-«f««i;  ^11  of  Rivbtft  «•  by  ^HftXA^Judioi^  iuduinl^tXAtive  octioti 
that  9^  Ar«  litajaiLly  ^•«£*t>a»  withr>ut  a  co.<»txy  aod  li^ipotcrntXy  vDic«l«»»  vio* 
ti«s  to  tho  ««iia»  of  oux  CA(*tor«  fxotQ  tha  Lnmtii^t  of  ^udici^i  |jxonoaocft«idnt 


ayi      tb«  FsdtixAl  rxi«on«x  Cc«&liti^»n'» 


lidru.&x   /\«   ^Au^x*   Co-iiixtrctox 


e/ 


989 


SUBJECT  NUMBER 


STATEMENT    -  ■  ~  '  :  "  '         "  ■ 

The  following  was  read  Co  inmate  volunteers  at  the  Connectitrut  Correctional  Institution, 
Soaiers,  Connecticut,  prior  to  their  participation  in  a  study  designed  to  compare  the 
bioavailability  of  two  [tablet  formulations  (Protocol  #72-037-14). 

1 
"The  study  in  which  you  are  about  to  participate  is  being  done  in  order  to  compare 

how  the  human  body  will  respond  to  the  two  tablets  of         f.  This  drug  is 

currently  sold  in  this  country  for  the  treatment  of  certain  infections.   \ 

"Based  on  previous  experience  with  this  drug  in  man,  the  following  side  effects  could 
occur:  nausea  and  diarrhea. 

"We  are  interested  in  comparing  what  happens  to  the  drug  givea  in  the  two  types  of 
tablets  once  it  enters  the  body.   The  blood,  and  urine  samples  which  are  to 
be  coilectad  during  tha  study  ■td.ll  help  ansvar  this  question  by  indicating  how  wall 
.~:hi  -Iru^  is  -dbsorbad  froa  -ha  3:iail  bowel,  .is  '..'ell  as  hew  foot  r-nd  in  v'nac  fora  ;ha 
^:-.-    is    -ilt'zi. ^.Si z id   irca  che  oad/. 

"'/oiuntaars  with  a  history  of  penicillin  allergy  will  be  escludad  from  this  study. 

"Tais  will  be  a  two  part  study  and  volunteers  may  participate  in  both  parts. 
TX'^enty-four  volunteers  will  be  selected  for  the  first  part  of  the  study  and  divided 
into  two  groups  of  twelve  men.   One  group  xrf.ll  receive  a  single  dose  of  the  first 
type  of  tablet  on  day  one  while  the  other  group  receives  the  second  type  of  tablet. 
Two  days  after  receiving  the  first  doses,  each  group  will  receive  the  other  tablet. 

"During  the  second  part  of  the  study,  the  twenty-four  volsaiteers  will  again. be 
divided  Into  two  groups  of  twelve  volunteers.  One  group  aS   subjects  will  receive 
one  tablet  of  drug  every  six  hours  for  six  consecutive  doses  while  the  second 
group  receives  two  tablets  of  drug  according  to  the  same  sraedule.         \ 


"As  with  all  our  studies,  your  reaction  to  the  medication  given  will  be  closely 
observed.  As  a  resxilt,  you  will  be  given  a  schedule  that  imist  be  followed  closely,  as 
any  break  In  this  schedule  may  result  in  data  which  is  of  ros  value. 

"Please  report  all  unpleasant  symptoms  to  the  Pfizer  nnrsfi. 

"You  are  free  to  withdraw  from  the  study  at  any  time. 

"Thank  you  for  taking  part  in  this  study.  Your  partic±patlBn  has  aided  in  the 
development  of  new  agents  for  the  treatment  of  infections  diseases. 


Associate  Director,  Clinical  Research  Pfizer  Nurse,  Cllalcal  Research. 

Pfizer  Inc.  Pflaer  Inc. 

Groton,  Connecticut  063A0  Groton,  Csnnectlcut   06340 

ATTESTED:  KME: 


Connecticut  Correctional  Institutioa 
SoTcers,  Connecticut 


TO  WHOM  rr  M.'VY  CONCERN 


I  have  read  the  above  statement  and  its  contents  and  meaning  have  been  explained  to 
na.   I  understand  that  Pfizer  Inc.  of  Groton,  Connecticut  wishes  to  administer 

to  human  subjects  to  observe  toleration  to  this  drug,  including  the  development  of 
any  undesirable  side  effects.   This  drug  is  experimental.   Bowever,  based  upon 
extensive  laboratory  tests,  it  is  considered  by  Pfizer  Inc.  to  be  safe  for  human 
administration. 

I  hereby  offer  my  services  as  a  subject  for  this  study.  "For  my  participation  I  am 

to  receive  a  minimum  of  $ for  participation  in  the  TOTiL  STUDY.   It  is 

understood  that  I  have  been  informed  of  the  possibility  of  ill  effects  and  risks 
involved  in  each  procedure.   If  I  am  permitted  to  participara  in  the  program,  I 
understand  chat  I  undertake  such  risks  of  my  own  free  will. 


I.i.'riata  ^lumbar  Daa_^  Asa         V-iiht 


990 


i 


INFORMATION  FOR  REVIEW  OF  PROPOSED  MEDICAL  STUDY 

1.  Title:     Ocular  Irrll-ation  Study  of  Baby  Shampoo 

2.  Purpose:     To  evaluate  the  potential  for  irritation  of  shampoo  used  for  babies. 

3.  .  Need  For  this  stud/:    To  be  sure  that  shampoo$(  used  for  babies)  do  not  cause  pain  or  injury  to  eyes. 

4.  Reoson  for  use  of  institutional  subjects:    Testing  must  be  done  under  supervision  on  several  subjects 
at  the  some  time.' 

5.  Number  and  age  of  subjects  needed:         20  subjects. 

6.  Duration  of  study:    2days. 

7.  Method  of  study:    0.1  ml  of  a  15%  dilution  of  the  shampoo  will  be  dropped  into  the  eye  of  subject. 

The  subject  will  be  questioned  and  examined  immediately  and  at  intervals  for  a 
period  of  24  hours. 

8.  Manufacturer  of  product  to  be  tested:     Johmson  and  Johnson  ii 

9.  Product  to  be  tested:    Baby  Shampoos.  1 

a.  Description: 

b.  Dosage:  One  drop  (0.1  ml)  of  15%  dilution  for  10  subjects  and  10  subjects  as  control:  10 
subjects  undiluted,  and  10  subjects  at  6%  dilution,  and  2  groups  of  10  subjects  each  as  controls,  j 

c.  Major  pharmacological  actions  or  effects:    None.  ' 


d.        Side  effects  and  related  dosage:     Possible  slight  Irritation. 


e.        Toxicity  and  related  dosage:    None. 


10.  Provisions  for  professional  supervision,  care,  hospitalization:     Subjects  will  be  examined  before  and 

after  by  an  Ophthalmologist. 

11.  Protocol:    Attached 

12.  Copy  of  consent  form:    Attached 

13.  Investigator  in  charge  and  any  consultants: 


HWC       6/72 


991 


(NFORMED   CONSENT    TO    PARTICIPATE    IN    MEDICAL   STUDY 


NFORMATION: 

1.  TiHe  of  Shudy:    Ocular  Irritation  Study  of  Baby  Shampoo 

2.  Purpose  of  Study:   To  evaluate  the  potential  for  irritation  of  shampoos  used  for  babies. 

3.  This  study  is  needed  to  find  the  potential  for  irritation  of  shampoos  used  for  babies. 

4.  it  Is  desirable  to  use  subjects  in  an  institution  because  frequent  supervision  and  observation  are 

necessary  and  require  restriction  of  subjects  activity. 

5.  Duration  of  Study:    Two  days. 

6.  Method  of  Study:     0.1  ml  of  15  %  dilusion  of  the  shampoo  v/ill  be  dropped  Into  the  eye  of  the 

subject.    The  subject  will  be  questioned  and  examined  immediately  and  at  Intervals 
for  a  period  of  24  hours. 

7.  Duties  of  Subjects:   To  have  eyes  examined  before  and  four  times  after  having  drops  of  solution 

placed  in  eye  and  report  any  effects. 

8.  Inconvenience/  discomfort  and  side  effects:       Examimation,  discomfort  of  eye  drop  and  possible  irritation 


9.        Hazards:  Irritation  of  membranes  covering  eye.    SlgnlTicant  Irritation  or  Injury  Is  very  unlikely. 
This  type  of  product  has  been  used  extensively  without  harmful  effects. 

10.         Provisions  for  medical  supervision  and  core:  An  Ophthalmologist  will  examine  subject  before  and 

after. 
ONSENT: 

I  hereby  consent  to  take  part  in  the  medlcol  study  described  above  under  the  supervision  of  Dr.  A.M.  Kligman 
understand  that  the  study  may  Involve  some  hazard  or  discomfort  and  some  unknown  risk  or  result.    This  and  my 
3rt  in  the  study  have  been  clearly  explained  to  me,  and  I  have  had  complete  freedom  to  ask  any  questions  about 
udy.     I  understand  and  consent  to  what  I  am  to  do  and  the  studies  to  be  performed  by  Dr. A.M.  Kligman  or  I 

islstant  in  properly  carrying  out  this  study. 

I  certify  that  I  am  at  least  twenty-one  years  of  age  and  that  I  have  freely  volur^teered  for  the  test  without  any 
rce,  pressure  or  Inducement  other  than  payment  for  the  study. 

I  understand  that  I  shall  receive  full  payment  If  I  am  removed  from  the  study,  or  If  I  choose  to  stop  because  )f 
Iness  or  suspected  effects  of  the  study  provided  I  permit  continued  observation  to  determine  the  cause  of  any  r  jcI 
Iness  or  suspected  effects. 

I  understand  that  I  do  forfeit  payment  If  I  am  removed  from  the  study  because  of  violation  of  institutional  reculc 
ons  or  failure  to  cooperate  In  the  study. 

Finally,   I  understand  that  neither  the  Philadelphia  Prisons  nor  the  City  of  Philadelphia  are  responsible  for  any 
ideslrable  effects  that  may  occur  because  of  the  study,  and  I  agree  that  I  shall  make  no  claim  against  them. 

I  agree  to  participate  in  this  study  In  consideration  of  payment  of  $   3.00  . 

ATE  SIGNATURE 


:GISTER  NO.  CELL  NO.  WITNESS 


GE  WEIGHT     '  HEIGHT  JOB  JOB  SUPERVISOR 


992 


MEMORANDUM 


I^obracry 


23;  \m\ 


|] 


TO 


FilOM 


Irv/iall.    jjvciilo'Cf,  M.D.  , 

Edward  J     Wcuclricr-,  Supoi-ir.tenUcnt  of  I-;:i:;cEiO 


i 


SUBJECT:         Medical  Tcctln?,  r.r-,.!  I^Jcneas-CiX  J^rctot^olv 


v;ork  iu  our  iiio-;ituticnD  ho.r.,   In  rny  opinion,  liTid  en  circcpliorjaUy 
flno  hioCory.      AU  dccco;*c  InvOdVod  hr>vc  beoivciv^^'aoi'dhi-^.i-'i^y 
caiiCiouo  ovon  to  tiio  polr^w  oX  bciirij  cci^'upuicuoki  Lrjoiu'hi^  Cir:.t  no 
jiS'ctOGo^o  cri-o  po;?.n-:Uccd  which  cou-d  hzkvo  cny  iac'lK^  Iiz^/i-rrJul 
CxiCQ'iO  oa  tbo  voiur.tCii'y.  p.ubjc.cCa.  .  Irowovo?,  E  thss:'-;  iu  view  oi  ', 

tb'C^v  urrJlc:;*  OL'd;:::i!;'y  ci.;;c;urAc5o.:'Cca  ;r.:;y  cccn'j  i:;:A*cc\i:^on2ibio  cr.d 
uni:ccoo.Oc:'t*y.      Tho  Bcrird  ot  T-juotoco  r.r.d  I  feci  Clr^i  If  cny  cl';;'OS 
cvo  to  bo  made  tiiwsy  chould  bo  rriiido  on  the  oido  c*  bei::^  ovq's'^- 
cauClouD. 


993 


Brculov/,   Rawunlcy  2  .  2/23/71 


EfjCGctivo  iiTin^ccliCitoly,   thorcforc,  I  ciLrectthat  no 
otucUcD  bo  undcrtakeii  in  which  any  amount,   po  mCities'  haw  Ginall, 
o^  any  ncircotic,   oi-  clarivr.tivo  of  navcotic,   couf^h  6up2:>roQr)tMi';D  or 
eubotituteo  ^ouXd  bo'x'oquired,  . 

It  io  furdioi-  directed  that  no  etudiet;  involving  tae 
uGo  of  fltiniulo-ats,   cedativcs  o:,*  trar*:]uilizerG  vvill  be  porinittod. 

And  finally,   ian-iatec  who  ere  in  cuotody  awaiting    . 
trial  or  sentoncc  aro  not  to  ho  UGcd  r.o  voluntcei*  oubjectti  in  any 


tL:dv' which ,V2i  11  require  the  adrninletratioi)  of  Ci?.y  cubc-lanco  orally 
parciiterillly  "    ,  .     '  .  ^ 

2*  viiti^c^'or:oui-j.y.       Tne  purposo  of  taio  !aat  alrection  io  to  prevent 
hny  poreovi  cwaitiiiQ  dicpocitioa  in  tho  cou^ta  to  clciim  thr.t  hio  pav- 
ticlpiitioi-i  in  r*  tootirj^  or  reccai-ch  projoct  had  a  delotoviouo  e^Xect 
on  hip  Gbiiity  to  participate  fully  and  coiiDtructlvoly  iii  hifj  ddcesise. 


JTdward  J.   Ilondriclc 
Superintendent 


EJK/acr 


ccr    Ed*-nund  K     Lyono,   AGflictr>nt  Super intcnclent  -  Opcratioao 
Joooph  P.   McGov/an.   Wai'dcn,   Jlohnocburc  Pricoa 
Pctrich  N.    Cuvvv,n,    Wai-don,   Dotontion  Cetitoj.* 
LouiD  S    Aytch.   V/ardon,   Houoo  of  Cci»roctioa 
John  B    Majiuii'e,  V/ardon,   Center  City  Dctcution  Cectoiv 


994 


cD  j;:  ^j?  "'ir     CD)  j^-     :E'^  jv:^i:  D/i  :'Zn  ./t^.  did)  jb  aCi;  j.:p  rr^iC  >::  ./r^s. 

HANDOLPH  f^  WISE  DEPARTMENT      OF      PUBLIC      VVcLFAFTi -J 

EUWAnrJ  J.  HENDiTICK  8201  STATE    ROAD,    PJIIUOEimiA,    PrNMA.    19136     lOi-3725 

«or»»i"Tci:pir»'T  or  r«noHt.  ... 


■    May  19,    1971 

MEMORANDUM 

TO  :  Albert  M.   Kligman,   M.  D. 

■Herbert  W.Copelan,   M".  D.  ■•■•'•:.'•;.' '  •        ' 

Irwin  H.    BreGlow,   M.  D.  >, 

Howard  M.   Rawnsley,   M.D. 

FROM        :  Edward  J.   Hendrick,   Superintendent  of  Prisons  ^ 

SUBJECT:  Medical  Teeting  aijd  Roeear.ch  Protocols 

Reference  (a)    -    My  Mcnioi'anduin  dated  2/23/71 

On  May  17,    1971,   I  proposed  to  the  Board  of  Trufitecs  a  modification  of 
reference  (a).      In  the  final  paragraph  of  that  memorandum,   I  directed  that 
"inmates  who  are  in  custody  awaiting  trial  or  sentence  are  not  to  be  used 
as  volunteer  subjects  in  any  stvidy  which  will  require  the  administration  of 
any  substance  orally  or  parenterally.       The  purpose  of  this  last  direction 
is  to  prevent  any  person  awaiting  disposition  in  the  courts  to  claim  that  his 
participation  in  a  testing  or  research  project  had  a  deleterious  effect  on 
his  ability  to  participate  fully  and  constructively  in  his  defense". 

Experience  has  shown  that  this  direction  v/as  perhaps  unnecessarily  stringent 
and  I  therefore  proposed  to  the  Board  of  Trustees  that  v/e  could  allow  the 
administration  of  nicdications  or  cubatances  that  cr.n  have  no  conceivable  effect 
on  thinl;ing,    personality  or  beliavior .       Exaniples  of  such  medications  would  be 
antibiotics,   aspirin,   aspirin-like  drxigs,   jnouth  rinses  and  antiseptics. 

The  Board  agreed  that  the  previous  direction  may  be  so  modified  and  amended. 
Hov/ever,   I  wish  to  emphasize  that  it  will  be  the  responsibility  of  all  investi- 
gators to  insure  that  no  medications  are  administered  to  this  group  which 
have  any  sedative,   tranquilizing  or.  stimulating  action,   no  matter  hov/  small. 


i 


^iM^M^i^h 


Edward  J.^Icndrick 
Superintendent 


f:jll/,v.fr  ^ 

•    .    .  I         '•.      ...      '..  ,  -         t  .    .*    T    ..^ .  .»      »  »  »     i<r  .  ..  ,1  ....  , 


I 


i 


995 


TO  John  Mc»ttioiii,    Deputy  City  SoJicitor  date   Jaii.uary  20,    J  97; 

FROM       :     JJclv.'c-rcl  J.   Hciidrick,   Supcrii)tei>danL  of  Pi-lrions 
surij=cT:     Mecljcal  Testing  Pro^osa],  No.    71 -105(H) 

In  accoi'dance  with  youi-  request  for  a  description  of  the  procedure  used  in 
proccEsing  the  subject  medical  testing  proposal,   J.  wish  to  advise  as  follows: 

This  proposal  wa.s  received  in  my  office  on  Axigust  30,    1971.     After  being 
assigned  a  proposal  nxuiiber,   the  project  description  papers  were  forwarded  to 
the  Vv''arden  of  the  institution  for  his  determination  that  he  can  spare  the  required 
number  of  inmates  for  participation  in  the  experiment.     After  approval  by  the 
V/arden,   the  papers  were  then  forwarded  to  Howard  M.   Rawnsley,   M.  D.  ,   who 
is  an  expert  pharmacologist,   and  has  been  retained  by  us  for  several  years  as 
an  independent  reviewer  of  all  medical  testing  proposals. 

On  September  7,    1971,    Dr.   Rawnsley  reconaniended  that  this  proposal 
could  be  approved  witli  the  following  provision:    "There  should  be  careful 
selection  of  the  subjects.       People  who  might  be  required  for  trial  or  testimony 
should  not  be  used.  "       Follov/ing  this  approval  by  Dr.  Rav/nsley,   I  gave 
permission  to  initiate  the  project  and,   as  is  clear  froni  the  attached  papers, 
repeated  in  my  approval  the  samfe  precautionary  ineasures  which  Dr.   Rawnsley-   • 
indicated. 

I  might  also  state  that  on  February  23,    1971,   I  directed  all  jnedical 
investigators  operating  in  the  prisons  that  no  studies  were  to  be  undertaken 
in  which  any  amount,   no  matter  how  snnall,    of  any  narcotic,   or  derivative  of 
narcotic,    cough  suppressants  or  substitutes  would  be  required.       I  further 
directed  that  no  studies  involving  the  use  of  stimulants,    sedatives  or  tranquilizer:, 
would  be  permitted  and  that  inmates  who  are  in  custody  awaiting  trial  or  sentence 
are  not  to  be  used  as  volunteer  subjects  in  ajpy  study  which  will  require  the 
adininistration  of  any  substance  orally  or  parenterally.       The  purpose  of  this 
last  direction  is  to  prevent  any  person  av/aiting  disposition  in  the  courts  to 
claim  that  his  participation  in  a  testing  or  research  project  had  a  deleterious 
effect  on  his  ability  to  participate  fully  and  constructively  in  his  defense. 

On  May  19,    1971  this  direction  wa.s  slightly  amended  as  shown  on  the  copy 
of  my  meiTiorandum  of  that  date. 

I  might  add  that  I  have  checked  and  been  informed  that  in  spite  of  the  fact 
that  permission  to  initiate  the  subject  project  was  given  on  September  9,  1971, 
the  study  has  never  been  undertaken. 


4^ 


mi^- 


Edwarll"^.   Hondricl^ 
Superintendent 
EJIl/acv 

F:ics, 

"•'■'-"'    ('■•"■  J'i'i  REscoHJ?;    TO   THIS    >.•.!;  MO^iANDU.M    m»v    o«   i.aos:    nrnroN    in   uomchano 


996 

[From  the  Philadelphia  Bulletin,  Aug.  25,  1966] 
U.  OF  P.  Doctor  Is  Reinstated  as  Drug-Tester  by  U.S.  Agency 

(By  David  M.  Oleary) 

The  U.S.  Food  and  Drug  Administration  has  restored  tlie  privileges  of  Dr. 
Albert  M.  Kligman,  University  of  Pennsylvania  dermatologist,  to  investigate 
drugs  as  a  step  toward  FDA  authorization  of  their  general  use. 

This  move  permits  Dr.  Kligman  to  resume  his  studies  of  the  effect  of  drugs 
upon  volunteers  from  Holmesburg  prison,  a  program  that  has  been  called 
outstanding  by  medical  authorities  and  provides  income  to  the  participating 
prisoners. 

Letters  signed  by  Winton  B.  Rankin,  deputy  commissioner  of  the  FDA, 
have  been  sent  to  33  drug  firms,  advising  them  that  restrictions  placed  upon  the 
acceptability  of  Dr.  Kligman's  work  by  the  FDA  on  July  19  have  been  lifted. 

NO  REASON    given 

No  reason  was  given  in  the  FDA  letter.  But  as  soon  as  Dr.  Kligman's  activities 
were  restricted,  many  medical  authorities  wrote  to  the  FDA  in  his  behalf. 

The  firms  that  had  placed  drugs  in  Dr.  Kligman's  hands  also  pointed  out  that 
they  considered  him  among  the  most  careful  and  qualified  investigators  in 
the  nation. 

Dr.  Kligman,  vacationing  at  Beach  Haven,  N.J..  could  not  be  reached  for 
comment  today.  But  his  attorney,  I.  I.  Jamison,  vacationing  at  another  seashore 
resort,  confirmed  that  the  restrictions  have  been  lifted. 

RECORDS    DIFFERED 

The  original  FDA  action  had  been  based  on  discrepancies  between  data 
reported  by  the  doctor  in  scientific  publications  and  records  on  file  at  Holmes- 
burg prison. 

In  one  example  cited  by  FDA  in  July,  it  was  alleged  that  an  inspector  found 
that  certain  men  whose  blood  was  reported  as  having  been  drawn  and  analyzed 
did  not  show^  on  prison  records  as  having  been  in  the  hospital  on  the  day 
in  question. 

Now,  acknowledging  that  the  errors  were  in  record-keeping,  rather  than 
scientific  integrity,  the  FDA  has  specified  that  administrative  work  must  be 
done  more  carefully  in  the  future. 

153    STUDIES 

The  original  complaint  against  Dr.  Kligman  arose  when  Dr.  Frances  O. 
Kelsey,  who  prevented  thalidomide  from  being  marketed  in  the  United  States 
(it  later  proved  to  cause  major  birth  defects  if  taken  by  pregnant  women) 
noticed  that  Dr.  Kligman  had  reported  153  separate  studies  in  recent  years,  and 
wondered  how  accurate  they  could  be  under  such  mass  production  conditions. 

The  investigation  of  prison  records  was  then  begun. 

Among  physicians  who  intervened  for  Dr.  Kligman  with  the  FDA  is  Dr. 
Donald  M.  Pillsbury,  emeritus  professor  of  dermatology  at  the  University 
of  Pennsylvania,  where  Dr.  Kligman  is  also  a  full  professor. 


[From  the  Philadelphia  Bulletin,  Aug.  25,  1966] 
Blacklisted  Specialist  Reinstated  by  FDA 

A  skin  specialist  at  the  University  of  Pennsylvania  has  been  reinstated  by 
the  Food  and  Drug  Administration  as  an  acceptable  investigator  of  new  drugs. 

Dr.  Albert  M.  Kligman  was  blacklisted  last  month  by  the  FDA  following 
an  investigation  which  allegedly  showed  that  the  dermatologist  had  kept  inade- 
quate and  misleading  records  involving  tests  on  volunteers  at  Holmesburg  Prison. 

Tlie  reinstatement  resulted  from  the  intervention  of  Dr.  Donald  M.  Pillsbury. 
emeritus  chairman  of  the  university's  dermatology  department,  who  promised  to 
monitor  Dr.  Kligman's  work  and  revamp  his  record  keeping  and  other  procedures. 

Neither  Dr.  Kligman  nor  Dr.  Pillsbury  could  be  reached  for  comment,  but  it 


997 

is  understood  that  the  problem  with  the  record-keeping  occurred  because  Dr. 
Kligman  had  relied  on  prison  trustees  to  do  much  of  this  work. 

Dr.  Kligman  gained  wide  acclaim  and  publicity  last  year  when  he  reported 
some  success  with  the  use  of  male  hormones  in  the  treatment  of  baldness. 

The  hormone,  called  testosterone,  somehow  stimulated  dormant  but  intact 
hair  follicles.  Long-time  baldness  did  not  respond  to  treatment. 

The  FDA's  blacklisting  of  Dr.  Kligman  almost  scuttled  wide-ranging  research 
work  at  Holmesburg  Prison. 

That's  because  the  work  was  partially  financed  through  fees  paid  by  drug 
companies  to  Dr.  Kligman  for  testing  their  drugs. 

The  FDA  last  month  informed  the  companies — there  were  33  of  them — that  no 
work  done  for  them  by  Dr.  Kligman  would  be  considered  acceptable  in  proving 
the  value  and  safety  of  their  drugs.  This  must  be  done  before  medicine  can  be 
put  on  the  market. 

The  FDA  confirmed  that  it  has  now  sent  out  second  notifications  to  the  manu- 
facturers telling  them  that  work  by  the  50-year-old  dermatologist  would  once 
more  be  acceptable. 

[From  the  Philadelphia  Bulletin,  Sept.  27,  19©6] 
Kligman  Admits  Inaccuracy  In  Scientific  Reporting 

(By  David  M.  Cleary) 

Dr.  Albert  M.  Kligman,  University  of  Pennsylvania  dermatologist,  today  admit- 
ted "a  regrettable  inaccuracy"  in  a  scientific  report  he  published  in  the  Journal 
of  the  American  Medical  Association  last  September. 

The  inaccuracy  was  one  of  several  cited  by  the  U.S.  Food  and  Drug  Adminis- 
tration on  July  19  in  advising  drug  manufacturers  that  studies  by  Dr.  Kligman 
would  no  longer  be  acceptable  as  evidence  of  drug  effectiveness  or  safety. 

FDA  Reinstates  Him 

A  month  later,  the  FDA  reinstated  Dr.  Kligman  as  a  drug  investigator,  on  con- 
dition that  he  supervise  his  subordinates  more  closely  and  keep  records  more 
carefully.  Thus  his  extensive  work  among  inmates  at  Holmesburg  Prison,  which 
has  been  hailed  by  medical  and  prison  authorities,  can  continue. 

Dr.  Kligman's  admission  of  error  is  contained  in  a  letter  published  in  today's 
issue  of  the  A.M.A.  Journal.  It  occurred  in  the  second  of  two  reports  on  dimenthyl 
sulfoxide  (DMSO),  a  controversial  drug  on  which  the  FDA  has  halted  all  further 
human  tests. 

"Owing  to  inadequate  supervision  on  my  part,"  wrote  Dr.  Kligman,  the  state- 
ments under  the  section  labeled  'Chronic  Exposure'  are  not  fully  supported  by 
the  experimental  procedures." 

20  Prisoners  in  Test 

In  the  test  in  question,  20  Holmesburg  inmates  were  said  to  have  had  the  drug 
applied  to  their  entire  trunks,  from  chin  to  pelvis,  each  day  for  26  weeks.  The 
doctor  reported  having  checked  the  men  for  ill  effects  at  regular  intervals  up 
to  the  24  th  week. 

The  FDA,  in  inspecting  Dr.  Kligman's  records,  could  find  no  evidence  that  any 
test  extended  beyond  the  1 6th  week. 

Dr.  Kligman  now  confirms  that  the  study  ended  at  16  weeks,  and  says  some  of 
the  men  dropped  out  even  earlier.  In  addition,  he  said  one  man  experienced  an 
untoward  reaction  (hives)  that  was  not  reported. 

Despite  these  discrepancies,  wrote  Dr.  Kligman,  "the  sum  of  accumulating 
experience  seems  likely  to  sustain  the  conclusion  of  low  topical  toxicity." 

Controversial  Issue 

The  conclusion  drawn  by  Dr.  Kligman  was  that  DMSO  had  potential  usefulness 
in  medical  practice,  and  that  it  was  safe  enough  for  further  experimentation  in 
humans. 

The  oflBcial  position  of  the  FDA  is  that  the  risks  are  greater  than  the  potential 
values,  and  on  this  basis  it  has  halted  testing  in  humans. 


93-999  O  -  73  -  pt.  3  --  14 


998 

The  DMSO  issue  is  one  of  controversy  in  medical  circles.  Earlier  this  month  a 
co-discoverer  of  its  medical  properties,  Dr.  Stanley  Jacob  of  the  University  of 
Oregon,  charged  that  the  FDA  may  he  "attempting  to  defend  a  position  rather 
than  attempting  to  determine  the  truth." 

Many  medical  authorities  support  Drs.  Jacob  and  Kligman  in  their  view  that 
DMSO  is  safe  when  properly  used.  Among  them  is  Dr.  Chauncey  D.  Leake,  past 
president  of  the  American  Association  for  the  Advancement  of  Science. 


[From  the  Philadelphia  Inquirer] 
Prisoner  Accused  of  Murder  Threat  By  Cellmate  in  Sex-Assault  Hearing — 

HOLMESBURQ  DEFENDANT  HeLD  FOR  GrAND  JuRY 

( By  Dennis  M.  Higgins ) 

A  36-year-old  inmate  of  Holmesburg  Prison  who  allegedly  used  his  power  as  a 
laboratory  assistant  with  a  medical  testing  program  to  help  ^seduce  other  prisoners 
was  accused  Thursday  of  threatening  to  kill  his  cellmate  if  he  did  not  submit 
to  indecent  acts. 

The  defendant,  Stanley  Randall,  of  Elizabeth,  N.J.,  was  held  for  the  grand 
jury  after  three  young  men  who  shared  his  cell  at  separate  times  had  testified 
he  engaged  in  perverted  sexual  acts  with  them. 

One  witness,  a  26-year-old  Massachusetts  prisoner  now  confined  in  the  House 
of  Correction,  told  Magistrate  Morris  Starr  in  the  Harbison  ave.  and  Levick 
St.  station  that  Randall  approached  him  last  April  18,  shortly  after  entered 
Holmesburg. 

PRISONER   TRANSFERRED 

"He  asked  me  if  I  was  new  and  I  said  yes,"  the  witness  said.  "He  said  he  want- 
ed me  to  be  in  his  cell  with  him.  I  said  okay  and  I  was  transferred  to  the  hospital 
block." 

That  night,  the  witness  said,  Randall  "brought  me  a  sandwich  and  said,  'How 
would  you  like  some  sex?"  I  said  I  don't  fool  around  with  that." 

Randall,  it  was  testified,  then  threatened  to  "throw  a  pair  of  scissors" 
through  his  cellmate's  heart.  Frightened,  the  witness  said  he  submitted  to 
Randall's  perversions  on  several  occasions. 

NO  OTHER  COMPLAINTS 

Randall  reportedly  made  $4000  a  year  while  working  for  the  University  of 
Pennsylvania  project.  Prisoners  he  "hired"  for  the  research  work  were  paid 
up  to  $10  a  day — a  fortune  in  the  institutional  world. 

Under  cross-examination  by  attorney  Neil  Leibman  the  witness  said  he  had 
no  other  sexual  contacts  in  prison.  He  said  Randall  worked  where  there  were 
"all  those  knives  and  scissors  laying  around"  and  he  did  not  complain  to  guards 
because  "I  don't  like  to  take  chances." 

Another  of  Randall's  former  cellmates  testified  that  he  submitted  "more  than 
10  times"  to  the  defendant's, will  during  a  period  from  February  to  April  1968. 

THIRD    WITNESS 

The  third  witness  for  the  Commonwealth,  a  19-year-old  boy  with  curly  blond 
hair,  said  shortly  after  being  sent  to  Holmesburg  last  July  he  "heard"  that 
he  was  going  to  be  "bothered"  by  other  prisoners  to  he  asked  for  a  transfer. 
He  was  moved  by  prison  guards  to  Randall's  cell. 

Randall,  he  said,  made  advances,  but  he  would  not  permit  the  lab  assistant 
to  fondle  him  "and  nothing  more  was  said." 

Leibman  asked  Magistrate  Starr  to  strike  all  testimony  by  the  three  on 
grounds  they  were  willing  co-conspirators.  Starr  denied  the  motion. 

It  was  disclosed  Thursday  that  a  prisoner  in  Holmesburg,  who  is  charged  with 
forcing  a  20-year-old  mental  defective  to  submit  to  his  sexual  advances,  attempted 
to  hang  himself  in  his  cell  late  Wednesday. 

Joseph  McDonnell,  21,  of  Roselyn  st.  near  3d,  was  confined  to  the  prison  hos- 
pital. His  case  was  continued  until  Oct.  18. 


999 

'NOTHING  WAS  DONE' 

The  victim  of  McDonnell's  alleged  assault,  who  has  been  permitted  to  sign 
his  own  bail  because  he  cannot  be  protected  behind  bars,  gave  testimony  against 
another  prisoner  during  examination  by  Assistant  District  Attorney  Robert 
Ginsberg. 

The  five-foot,  two-inch  complainant  said  Larry  Burkett,  20,  of  6th  st.  near 
Clearfield,  committed  homosexual  rape  against  him  last  June  13  in  a  room  near 
the  prison  gymnasium. 

The  witness  said  he  told  a  guard  lieutenant,  who  sent  him  to  the  hospital  a 
week  later,  "but  nothing  was  done  about  it."  No  complaint  was  made  to  police 
in  behalf  of  the  witness  until  after  the  heralded  investigation  of  jailhouse 
homosexuality  began. 

[From  the  Philadelphia  Inquirer] 
Lab  Testing  Program  Tied  to  Prison  Sex  Corruption 

(By  William  B.  Collins) 

A  laboratory  testing  program  headed  by  a  University  of  Pennsylvania  der- 
matologist was  accused  on  Wednesday  of  being  a  major  source  of  corruption  at 
Holmesburg  Prison,  in  a  report  on  homosexual  abuses  in  Philadelphia's  prison 
system.  The  report  said  that  one  inmate  made  so  much  money  from  the  project 
that  he  was  able  to  choose  his  cellmates  and  subvert  them  sexually  with  bribes. 

DEFENDS  program 

The  project  "has  had  a  generally  disastrous  effect  on  the  operation  of  Holmes- 
burg Prison  and  is  one  of  the  major  reasons  why  employe  morale  is  lowest  in  that 
institution,"  the  report  said. 

Superintendent  of  Prisons  Edward  J.  Hendrick  defended  the  program  as  a 
useful  one  which  gave  prisoners  a  chance  to  earn  pocket  money. 

Dr.  Albert  M.  Kligman,  professor  of  dermatology  at  the  University  of  Penn- 
sylvania's School  of  Medicine,  said  it  was  "vile"  to  associate  the  program  with 
homosexual  abuses. 

SERVE  AS  GUINEA  PIGS 

In  the  project,  volunteer  inmates  are  used  as  guinea  pigs  for  testing  medicines, 
drugs  and  commercial  products  like  soaps,  shaving  cream,  sun  tan  lotions  and 
toilet  tissue. 

Dr.  Kligman  said  the  project  involved  tests  for  Ivy  Laboratories,  of  which  he 
is  president,  and  some  research  by  resident  doctors  at  the  university. 

"Every  inmate  at  Holmesburg  wants  to  'get  in  on  the  tests',  "  the  report  said. 
"By  prison  standards,  they  can  earn  a  fortune.  For  example,  they  can  earn  $10 
or  $15  a  week  by  ju^t  wearing  a  chemical  patch  on  their  back." 

Holmesburg  inmates  earn  more  than  $250,000  a  year  from  the  testing  program, 
the  report  said. 

Until  recently,  some  prisoners  were  used  as  laboratory  assistants,  making 
$100  a  month — "a  millionaire's  income  in  the  context  of  the  prison  economy," 
the  report  states. 

One  inmate  lab  assistant,  according  to  the  report,  had  broad  power  to  deter- 
mine which  prisoners  would  be  selected  for  the  tests  and  controlled  the  disburse- 
ment of  between  $10,000  and  $20,000  a  year. 

He  was  identified  as  Stanley  Randall,  38,  a  "fraud  artist,"  serving  a  4-to-ll- 
year  sentence. 

BRIBED  NEWCOMERS 

Randall's  specialty  "was  newly  admitted  young  men,"  the  report  said,  charg- 
ing that  he  used  his  position  to  bribe  newcomers  into  sodomy. 

One  of  Randall's  cellmates  earned  over  $800  in  six  months  and  another  made 
$1740  in  11  months,  the  report  charged. 

Investigators  said  they  were  told  that  a  guard  lieutenant  had  given  orders  not 
to  interfere  with  the  prisoner  lab  assistants.  The  lieutenant  denied  this  but 
refused  to  take  a  lie  detector  test,  the  report  says. 

The  report  said  another  inmate  worker  faked  test  results  and  fee  vouchers, 
thus  channeling  money  to  prisoners  who  never  served  as  subjects. 


1000 

"It  also  seems  that  at  least  a  few  guards  themselves  were  corrupted,"  the 
report  said. 

GUARDS    INVOLVED 

"Although  this  aspect  of  the  investigation  continues,  the  full  extent  of  the 
inmates  and  staff  corruption  surrounding  the  test  project  probably  will  never  be 
known." 

The  investigators,  headed  by  Chief  Assistant  District  Attorney  Alan  J.  Davis, 
said  the  "project  mess"  could  have  been  averted  by  "even  rudimentary  super- 
vision" by  prison  authorities. 

PRISON    GETS    20    PERCENT 

Since  the  investigation  began,  the  project  has  stopped  employing  prisoners 
as  lab  assistants. 

The  project  pays  20  percent  of  the  prisoners'  wages  to  the  prison  system.  Dr. 
BCligman  said,  "We  want  to  pay  our  own  way  so  the  city  cannot  be  said  to  be 
supporting  this. 

"We  are  closely  supervised,"  Dr.  Kligman  said. 


[From  the  Philadelphia  Inquirer] 
Prison  Study  Ties  Lab  Tests  to  Corruption 

(By  William  B.  Collins) 

A  laboratory  testing  program  headed  by  a  University  of  Pennsylvania  derma- 
tologist was  accused  on  Wednesday  of  being  a  major  source  of  corruption  at 
Holmesburg  Prison,  in  a  report  on  homosexual  abuses  in  Philadelphia's  prison 
system. 

The  report  said  that  one  inmate  made  so  much  money  from  the  project  that  he 
was  able  to  choose  his  cellmates  and  subvert  them  sexually  with  bribes. 

defends  program 

The  project  "has  had  a  generally  disastrous  effect  on  the  operation  of  Holmes- 
burg Prison  and  is  one  of  the  major  reasons  why  employe  morale  is  lowest  in 
that  institution,"  the  report  said. 

Superintendent  of  Prisons  Edward  J.  Hendrick  defended  the  program  as  a 
useful  one  which  gave  prisoners  a  chance  to  earn  pocket  money. 

Dr.  Albert  M.  Kligman,  professor  of  dermatology  at  the  University  of  .Penn- 
sylvania's School  of  Medicine,  said  it  was  "vile"  to  associate  the  program  with 
homosexual  abuses. 

SERVE   AS    GUINEA   PIGS 

In  the  project,  volunteer  inmates  are  used  as  guinea  pigs  for  testing  medicines, 
drugs  and  commercial  products  like  soaps,  shaving  cream,  sun  tan  lotions  and 
toilet  tissue. 

Dr.  Kligman  said  the  project  involved  tests  for  Ivy  Laboratories,  of  which  he 
is  president,  and  some  research  by  resident  doctors  at  the  university. 

"Every  inmate  at  Holmesburg  wants  to  'get  in  on  the  tests.'  "  the  report  said. 
"By  prison  standards,  they  can  earn  a  fortune.  For  example,  they  can  earn  $10 
or  $1.5  a  week. 

Until  recently,  some  prisoners  were  used  as  laboratory  assistants,  making  $100 
a  month — "a  millionaire's  income  in  the  context  of  the  prison  economy,"  the  re- 
port states. 

One  inmate  lab  assistant,  according  to  the  report,  had  broad  power  to  deter- 
mine which  prisoners  would  be  selected  for  the  tests  and  controlled  the  disburse- 
ment of  between  $10,000  and  $20,000  a  year. 

He  was  identified  as  Stanley  Randall,  38,  a  "fraud  artist,"  serving  a  4-to-ll-year 
sentence. 

BRIBED    NEWCOMERS 

Randall's  specialty  "was  newly  admitted  young  men,"  the  report  said,  charging 
that  he  used  his  position  to  bribe  newcomers  into  sodomy. 

One  of  Randall's  cellmates  earned  over  $800  in  six  months  and  another  made 
$1740  in  11  months,  the  report  charged. 


1001 

Investigators  said  they  were  told  that  a  guard  lieutenant  had  given  orders  not 
to  interfere  with  the  prisoner  lab  assistants.  The  lieutenant  denied  this  but  re- 
fused to  take  a  lie  detector  test,  the  report  says. 

The  report  said  another  inmate  worker  faked  test  results  and  fee  vouchers, 
thus  channeling  money  to  prisoners  who  never  served  as  subjects. 

"It  also  seems  that  at  least  a  few  guards  themselves  were  corrupted,"  the  re- 
port said. 

[From  Time,  Sept.  17,  1965] 
Drugs — A  Limited  Wonder 

No  new  and  virtually  untested  drug  has  ever  been  greeted  with  such  optimistic 
fanfare  as  dimethyl  sulfoxide,  or  DMSO,  a  colorless  liquid  extracted  from  paper- 
pulp  wastes  and  commonly  used  as  an  industrial  solvent.  It  has  been  widely 
hailed,  both  in  the  press  and  by  some  doctors,  as  a  painkiller,  a  germ  killer,  c^iure- 
tic,  transquilizer,  a  reliever  of  bums  and  sprains — besides  being  a  wonderous 
solvent  that  enables  other  drugs  to  penetrate  the  skin  and  alleviate  conditions 
as  varied  as  crippling  arthritis  and  athlete's  foot.  The  surgeon  who  discovered 
DMSO's  medicinal  properties  in  1963,  Dr.  Stanley  W.  Jacob,  41,  of  the  University 
of  Oregon,  says  extravagantly  that  it  has  other  possible  uses  too  fantastic  to 
disclose.  The  highly  purified,  medicinal  form  of  DMSO  is  not  yet  on  the  prescrip- 
tion market,  but  pain-racked  arthritis  victims  have  been  paying  $3.50  an  ounce 
for  bootlegged  crude  commercial  DMSO,  which  may  be  dangerous. 

Hitching  Rides.  Up  to  now,  the  claims  for  DMSO  had  not  been  proved  by  care- 
ful investigation.  But  in  this  week's  A.M.A.  Journal,  Dr.  Albert  M.  Kligman,  a 
University  of  Pennsylvania  professor  of  dermatology,  supplies  many  of  the  over- 
due answers. 

After  the  most  thorough  study  yet  made  of  the  drug,  with  state  prison  in- 
mates who  volunteered  for  tedious  and  sometimes  painful  tests.  Dr.  Kligman 
offers  some  negative  findings.  DMSO,  he  says,  provides  practically  no  relief  for 
itching  or  superficial  pain.  As  a  germ  killer,  it  is  weak  "and  far  inferior  to  al- 
cohol." It  does  nothing  to  promote  the  healing  of  clean,  simple  bums,  and  it 
worsened  one  of  ten  ultraviolet  bums.  DMSO  also  failed  to  tranquilize  any  of  20 
men  in  a  six-month  test.  Nevertheless,  it  has  some  remarkably  beneficial  prop- 
erties. 

Almost  all  the  good  effects  result  from  the  drug's  unrivaled  ability  to  pass 
through  human  skin  like  a  hot  knife  through  butter.  And  since  so  many  other 
drugs  dissolve  readily  in  DMSO,  they  can  hitch  a  ride  with  it  and  quickly  pene- 
trate the  homy  (outer)  layers  of  the  skin,  thus  reaching  hitherto  inaccessible 
areas.^ 

Spare  the  Needle.  Other  physicians  have  been  cautiously  trying  DMSO  on 
selected  patients,  and  draw  these  tentative  conclusions : 

As  a  treatment  for  advanced  rheumatoid  arthritis,  which  affects  the  entire 
body,  DMSO  alone  is  no  better  than  present  drugs,  but  some  rheumatologists 
believe  it  helps  markedly  in  acute  flare-ups  in  the  earlier  stages  of  the  disease. 

In  less  severe  rheumatic  conditions  involving  only  one  or  two  joints,  such  as 
bursitis  and  "tennis  elbow,"  DMSO  may  spare  the  patient  a  painful  injection 
into  the  middle  of  the  joint.  Doctors  disagree  as  to  how  much  of  a  cortisone-type 
drug  dissolved  in  DMSO  soaks  into  the  joint,  but  patients  report  that  they  feel 
better  and  they  are  grateful  for  being  spared  the  needle. 

For  fungal  infections  such  as  ringworm  and  athlete's  foot,  DMSO  transports 
the  basic  antifungal  drug  and  helps  to  speed  clearing  of  the  infection.  Dr.  Klig- 
man finds  that  DMSO  itself  has  moderate  antifungal  powers. 

DMSO  is  also  helpful  in  scleroderma  or  "hidebound  disease,"  in  which  the 
skin's  fibrous  middle  layer  becomes  thickened  and  so  hard  that  the  victim 
cannot  clench  his  hands.  Cleveland  Clinic's  Dr.  Arthur  L.  Scherbel  reports  that 
daily  paintings  with  DMSO  have  restored  the  use  of  the  hands,  and  healed  finger- 
tip ulcers.  He  is  not  yet  certain  whether  DMSO  has  long-term  effects  on  the 
overall  disease. 

The  Food  and  Drug  Administration's  chief  of  drug  investigations.  Dr.  Frances 
O.  Kelsey,  is  strictly  controlling  DMSO's  use  by  limiting  supplies  to  approved 
researchers.  With  so  much  still  to  be  learned,  DMSO  cannot  go  on  general 
prescription  sale  for  at  least  one  year  and  more  likely  three. 


1  How  far  and  fast  It  travels  is  shown  by  the  fact  that  a  minute  or  two  after  it  is  swabbed 
on  the  skin  it  creates  a  garlic  odor  on  the  patient's  breath. 


1002 

To  the  Editor. — I  wish  to  inform  you  of  a  regrettable  inaccuracy  in  Part  2  of 
my  paper  enitled.  "Topical  Pharmacology  and  Toxicology  of  Dimethyl  Sulfox 
ide"  (193:923  1965).  Owing  to  [inadequate  supervision  on  my  part]  the  state- 
ments under  the  section  labeled  "Chronic  Exposure '  (p.  925)  are  not  fully  sup- 
ported by  the  experimental  procedures. 

Twenty  men  were  to  have  received  9  ml  of  90%  dimethyl  sulfoxide  to  the  trunk 
once  daily  for  24  weeks.  Actually  the  study  was  stopped  at  16  weeks.  Moreover, 
some  subjects  dropped  out  before  this  time  for  unrelated  reasons.  One,  however, 
experienced  giant  hives  on  the  trunk  at  night,  a  few  days  after  starting.  He  was 
not  continued.  In  reviewing  the  summation  of  the  toxicologic  data  I  failed  to 
note  this  happening,  although  it  was  duly  noted  on  the  chart.  I  did  however 
call  attention  to  the  possibility  of  hisamine  mediated  shock-like  syndromes. 
Since  20  subjects  were  not  treated  for  the  full  period,  the  laboratory  data  as 
given  cannot  be  accepted  as  properly  validated. 

Despite  the  failure  to  perform  the  test  as  reported,  the  sum  of  accumulating 
experience  seems  likely  to  sustain  the  conclusion  of  low  topical  toxicity. 

Albert  M.  Kligman,  M.D., 

Philadelphia. 

[From  Time,  Aug.  5,  l&e6] 
Drug  Regulation — Investigating  the  Investigator 

For  only  the  second  time  in  its  history,  the  Food  and  Drug  Administration 
last  week  struck  a  physician's  name  from  its  approved  list  of  researchers  who 
are  entitled  to  test  new,  investigational  drugs  on  human  subjects.  Tlie  target 
of  the  FDA's  action  was  Dr.  Albert  M.  Kligman,  a  Philadelphia  dermatologist, 
along  with  "all  investigators  associated  with'  three  incorporated  laboratories  of 
which  he  is  president  and  director. 

Only  last  year  Dr.  Kligman,  a  full  professor  in  the  University  of  Pennsylvania 
School  of  Medicine,  published  what  was  then  hailed  as  "the  most  thorough 
study  yet  made"  of  DM  SO,  the  controversial  drug  solvent  that  has  been  billed 
as  a  remedy  for  everything  from  arthritis  to  athlete's  foot  (Time,  Sept.  17,  1965). 
It  developed  that  Dr.  Kligman  and  his  labs  were  investigating  new  drugs  for 
no  fewer  than  33  manufacturers,  and  the  FDA's  Dr.  Frances  O.  Kelsey,  of 
thalidomide  fame,  began  to  wonder  how  thoroughly  and  carefully  Kligman  & 
Co.  could  do  all  that  work.  A  check  of  the  DMSO  study  showed  that  Dr.  Kligman 
i-^ported  tests  on  three  groups  of  prison  volunteers,  but  prison  records  turned 
up  only  two  groups.  In  the  Kligman  report,  these  tests  ran  for  24  and  26  weeks, 
but  prison  records  showed  only  16  weeks. 

The  FDA  charges  that  one  prisoner  had  a  severe  reaction  to  DMSO,  but  that 
this  was  not  acknowledged  in  the  Kligman  report,  that  Dr.  Kligman  allowed 
his  comparison  subjects  to  take  other  investigational  drugs,  instead  of  a  dummy 
( placebo)),  thus  rendering  his  conclusions  meaningless,  and  that  he  reported 
blood  tests  on  patients  who  were  not  even  in  the  hospital  at  the  time  he  claimed. 
Dr.  Gligman  has  the  right  to  ask  the  FDA  to  review  its  action. 


[From  the  National  Police  Gazette.  February  1970] 
Sex  Traffic 

Another  report  submitted  to  the  Senate  Committee  puts  the  spotlight  on 
commercialized  traflSc  in  young  men  that  exists  behind  prison  walls. 

Here  is  an  oflficial  report  given  Senator  Dodd  by  the  District  Attorney  of 
Philadelphia. 

"Homosexual  favors  can  be  purchased  in  the  Philadelphia  prison  system  with 
luxuries  such  as  cigarettes,  sedatives,  stainless  steel  blades,  candy  or  extra 
food  pilfered  from  the  kitchen.  Although  theoretically  segregated  from  the  gen- 
eral prison  population,  confirmed  homosexuals  known  as  'sissys'  'freeks'  or  'girls' 
are  readily  available  as  male  prostitutes. 

"Investigators  learned  of  repeated  instances  where  homosexual  'security' 
units  were  left  unguarded  by  an  overextended  and  sometimes  indifferent  staff, 
and  even  of  some  cases  where  guards  unlocked  cells  housing  homosexuals,  or 
turned  their  backs,  so  that  certain  favored  inmates  could  have  homosexual 
relations. 

"In  some  instances  male  prostitutes  are  created  by  a  combination  of  bribery, 
persuasion  and  the  threat  of  force. 


1003 

"Typically,  an  inexperienced  young  man  will  be  given  cigarettes,  candy  and 
other  items  by  another  more  experienced  inmate,  who  after  a  few  days  will 
demand  sexual  repayment. 

"Similarly,  an  inexperienced  inmate  will  be  enticed  into  large  gambling  debts 
and  then  told  to  pay  off. 

"Of  course,  the  initial  voluntary  homosexual  act  indelibly  stamps  the  victim 
as  a  "punk  boy,"  and  he  is  pressed  into  prostitution  for  the  remainder  of  his 
imprisonment. 

"The  common  thread  in  this  category  of  cases  is  the  employment  of  economic 
advantage  to  obtain  sexual  advantage. 

"Unfortunately  it  is  virtually  impossible  to  obliterate  economic  distinctions 
between  inmates. 

"In  a  prison  economy  where  a  shopworker  earns  15  to  25  cents  a  day,  where 
more  than  half  the  inmates  have  no  prison  job  at  all,  and  where  most  inmates 
get  little  or  no  help  from  outside  the  institution,  even  a  small  accumulation 
of  luxuries  or  money  can  give  an  inmate  substantial  economic  leverage. 

"As  a  result,  at  least  one  inmate  became  so  economically  powerful  that  he  was 
able  to  choose  as  cellmates  a  series  of  young  men  attractive  to  him,  and  sexually 
subvert  each  one  by  bribery. 

"A  brief  description  of  the  case  follows : 

"The  University  of  Pennsylvania  and  a  private  concern  named  Ivy  Laboratories 
operate  a  large  laboratory  on  'H'  Block  of  Holmesburg  prison  where  they  test 
on  inmates  medicines,  experimental  drugs  and  commercial  products  such  as 
shaving  cream  and  sun  tan  lotions. 

"Prisoners  are  excellent  human  guinea  pigs  because  they  live  under  controlled 
conditions  and  will  submit  to  tests  for  a  fraction  of  the  fee  that  would  be  de- 
manded by  the  ordinary  free  individual. 

"Because  there  is  a  dearth  of  alternative  programming  at  Holmesburg,  and 
because  the  project  pays  20  percent  of  the  inmates  wages  to  the  prison  system, 
prison  administrators  have  allowed  the  project  to  expand  to  the  point  where  it 
constitutes  a  separate  government  within  the  prison  system. 

"Every  inmate  at  Holmesburg  wants  to  get  on  the  tests.  By  prison  standards 
they  can  earn  a  fortune. 

"For  example,  they  can  earn  $10  to  $15  dollars  a  week  by  just  wearing  a  chem- 
ical patch  on  their  back. 

"Some  tests  lasting  longer  periods  will  pay  over  $100  for  doing  virtually 
nothing. 

"All  told  the  Holmesburg  inmates  earn  more  than  a  quarter  of  a  million  dollars 
each  year  from  the  project. 

"Of  course,  a  few  prisoners  end  up  with  bodies  crazy-quilted  with  different 
colored  reactions  and  scars,  but  in  the  context  of  the  prison  economy  it  all  seems 
worth  it  to  the  prisoners. 

GUARDS  ON  PAYROLL 

"The  operators  of  the  project  save  additional  money  by  using  inmates  as  labor- 
atory assistants.  An  experienced  assistant  working  an  8  hours  day  gets  $100  a 
month,  a  millionaire's  income  in  the  context  of  the  prison  economy. 

"Even  some  prison  guards  are  employed  in  the  project. 

"The  U  of  P  project  has  had  a  generally  disastrous  effect  on  the  operation  of 
Holmesburg  Prison. 

"But,  if  the  project's  general  effects  have  been  disastrous,  in  one  specific  aspect 
it  has  been  outrageous. 

"Stanley  Randall,  a  38-year-old  fraud  artist  serving  a  4  to  11  year  sentence, 
was  employed  in  laboratory  cell  806.  'H'  Block,  as  an  inmate  assistant. 

"Although  prison  and  project  officials  at  first  denied  it.  Randall  had  the  power 
within  very  broad  limits  to  select  which  inmates  would  serve  as  subjects  on  which 
tests. 


[From  the  New  York  Times.  Dec.  31.  1972] 
,  Prisoners,  Not  Guinea  Pigs 

(By  Tom  Wicker) 

Durham,  X.C. — Dr.  Martin  Groder  is  a  young  psychiatrist  for  the  Federal 
Bureau  of  Prisons.  Contrary  to  much  contemporary  thought,  he  believes  in  the 
possibility  of  rehabilitating  prisoners  because,  he  says,  "I've  done  it." 


1004 

That  was  at  the  Federal  prison  in  Marion,  111.,  where  Dr.  Groder  (33,  and  a 
jrraduate  of  both  Columbia  Medical  School  and  the  Langley  Porter  Neuropsy- 
chiatric  Institute  at  the  University  of  California)  claims  to  have  had  some  success 
tV'ith  programs  "in  which  the  prisoners  get  interested  and  invest  themselves."  He 
says  he  relies  primarily  on  "transactional  analysis" — about  which  many  people 
read  in  Eric  Berne's  "Games  People  Play."  His  ideas  also  are  heavily  influenced 
by  two  years'  work  with  the  Synanon  Institute  in  California,  which  has  been 
Successful  in  rehabilitating  some  drug  addicts. 

Dr.  Groder  is  developing  and  will  be  the  director  of  the  new  Federal  Center 
for  Correctional  Research,  now  being  built  at  a  cost  of  $13.5  million  at  Camp 
Butner,  an  old  Army  post  near  here.  It  is  scheduled  to  open  in  1974  with  a  staff 
of  211.  with  140  psychiatric  beds  for  short-term  treatment  of  severely  disturbed 
Federal  prisoners,  and  places  for  200  other  selected  prisoners  in  four  "research 
units." 

These  plans  run  counter  to  at  least  two  main  lines  of  thought  among  modern 
penologists  and  organizations  in  terested  in  corrections.  One  such  line  is  that 
prisons  themselves  are  the  real  correctional  problem — that  no  rehabilitation  pro- 
gram can  overcome  the  bad  effect  of  the  institution  itself  on  the  prisoner.  The  Na- 
tional Council  on  Crime  and  Delinquency,  for  example,  is  critical  of  the  Bureau  of 
Prisons'  $60-million  construction  program,  of  which  the  Federal  Center  at  Butner 
is  a  part.  The  council  advocates  instead  "community  correction  programs  that 
deal  with  the  offender  in  his  own  community." 

Prison-run  "behavior  research"  is  in  bad  odor,  moreover,  among  those  who 
have  studied  its  workings  at  such  state  institutions  as  Vacaville  in  California  and 
Patuxent  in  Maryland.  This  is  because,  under  the  guise  of  mental  treatment  of 
patients,  such  institutions  have  done  things  to  prisoners — electroshock,  psycho- 
surgery, massive  drugging,  and  the  like — to  which  no  court  would  sentence  them ; 
and  because  some  of  these  institutions  have  seized  on  indeterminate  sentencing 
procedures  to  keep  prisoners  under  such  treatment  long  past  the  time  they  might 
have  served  in  an  ordinary  prison.  Generally,  most  prison  "rehabilitation,"  pro- 
grams have  been  chargesd  with  trying  mainly  to  produce  docile  prisoners,  rather 
than  stable  citizens. 

Martin  Groder  is  cheerfully  aware,  therefore,  that  the  new  Federal  Center 
he  will  head  is  suspect  in  some  circles — not  least  among  Federal  prisoners,  who 
are  not  anxious  to  be  "guinea  pigs"  in  behavior  research.  He  is  nevertheless 
pressing  ahead  in  the  belief  that  a  major  contribution  to  corrections  problems  can 
be  made  at  Butner.  He  argues  that  the  new  center  is  already  an  improvement 
on  the  original  Bureau  of  Prisons  plan  to  use  the  Butner  site  for  a  big  com- 
bined prison  and  mental  hospital — what  Dr.  Groden  says  would  have  been  a 
'psychiatric  warehouse"  for  disturbed  prisoners. 

As  for  the  evils  of  "behavioral  research"  in  other  prisons,  both  Dr.  Groder,  in 
an  interview  at  his  office  in  Durham,  and  his  superiors  in  Washington  firmly 
deny  that  the  Federal  Center  at  Camp  Butner  will  employ  such  "treatment." 
Among  the  200  prisoners  to  be  assigned  to  the  research  units  from  other  Federal 
prisons,  there  will  be  none  with  indeterminate  sentences,  for  one  thing,  so  the 
center  will  have  no  power  to  hold  them  past  their  scheduled  release  dates. 

Dr.  Groder  argues,  on  a  professional  basis,  that  "repressive  methods  that 
push  people  around"  don't  work.  He  has  no  plans,  he  pledges,  for  "rehabilitating" 
prisoners  by  surgery,  drug  therapy  or  "aversive  treatment" — the  sort  of  thing 
moviegoers  saw  in  "A  Clockwise  Orange,"  when  a  young  offender  was  made  to 
feel  severe  pain  in  connection  with  thoughts  of  criminal  acts. 

Electroshock,  if  used  it  all,  Dr.  Groder  says,  will  be  limited  to  supervised  treat- 
ment of  mental  patients,  as  in  a  civilian  hospital,  and  will  not  be  part  of  the  re- 
search program.  Nor  will  the  rehabilitation  experiments  offer  the  kind  of  "re- 
wards" that  consist  of  putting  a  prisoner  in  painful  or  degrading  circumstances, 
then  gradually  improving  his  environment  as  he  becomes  more  docile  and  respon- 
sive to  the  authorities. 

Btit  if  all  that  is  true,  and  if  the  abuses  alleged  to  have  occurred  at  Vacaville, 
Patuxent  and  elsewhere  are  to  be  avoided  at  Butner,  the  question  still  remains 
whether  Dr.  Groder  and  the  staff  he  is  beginning  to  put  together  can  really  re- 
habilitate offenders  in  programs  carried  out  within  a  prison  institution — a  task 
many  students  of  the  corrections  system  have  come  to  consider  impossible.  The 
answer  is  by  no  means  certain,  but  as  will  be  seen  in  another  article,  Martin 
Groder  thinks  it's  well  worth  a  try. 


1005 

CORRESPONDENCE  DEALING  WITH 
BUREAU  OF  PRISONS  PROJECTS 
INVOLVING  BEHAVIOR  MODIFICATION 


1006 


JOHN  I..  MCCLEUL>N.  ARK. 
SAM  J,  ERVIN.  JR..  N.C. 
PHILIP  A.  HART.   MtCH. 
EDWARD  M.  KENNEDY,  MASS. 
BIRCH  BAYH.  IND. 
OUENTIN  N.  BURDICK.  N.  DAK. 
ROBERT  C.  8YRO,  W.VA. 
JOHN  V.  TUNNEY,  CALIF. 


JAMES  O.  EASTLAND,  MISS.,  CHAIRMAN 

ROMAN  L.  HRUSKA,  NEQR. 

HIRAM  1-.  FONO.  HAWAII 

HUOH  SCOTT,  PA. 

STROM  THURMOND.  6.C. 

MARL.OW  W.  COOK,  KY. 

CHARLES  MCC.  MATHIAS,  JR.,  MO. 

EDWARD  J.  OURNEV,  FUk. 


SUBCOMMITTEei 

SAM  J.  ERVIN,  JR.,  NX.,  CHAIRMAN 

JOHN  L.  MC  CLELLAN.  ARK.  ROMAN  L.  HRUSKA.  NEBIC 


EDWARD  M.  KENNEDY,  MASS, 
BIRCH  BAYH,  IND. 
ROBERT  C.  BYRD,  W.  VA. 
JOHN  V,  TUNNEY,  CAUF. 


HIRAM  L.  FONO.  HAWAII 
STROM  THURMOND,  SX, 
HUGH  SCOTT,  PA. 


^irxxleh  ^icxie^  JS>encxic 

COMMITTEE  ON  THE  JUDICIARY 

SUBCOMMITTEE  ON  CONSTITUTIONAL  RIGHTS 

(pursuant  TO  SEC  i,  S.  RES.  IM,  KO  CONORKaa) 

Washington.  O.C.   20510 

December  21,  1972 


Mr.  Norman  A,  Carlson 

Director 

Bureau  of  Prisons  ' 

Department  of  Justice  < 

Washington,  D.C. 

Dear  Mr.  Carlson: 

It  has  come  to  my  attention  that  the  Bureau  of  Prisons  is  con- 
structing a  $12.5  million  facility  at  Butner,  North  Carolina.  The  center 
is  apparently  designed  for  "behavior  modification"  and  is  intended  as  a 
model  for  the  entire  federal  prison  system.  The  precise  purpose  and 
scope  of  this  unit  at  Butner  is  most  unclear.  To  my  knowledge,  there 
has  been  no  mention  in  the  Bureau's  statements  to  Congress  of  exactly 
what  type  of  programs  are  planned  for  the  Butner  facility.  It  appears 
also  that  a  Pro.ject  START  is  to  be  implemented  at  the  Springfield, 
Missouri  Medical  Center.  The  dimensions  of  this  project  as  revealed  in 
the  Bureau's  October  25,  1972,  memorandum  are  also  unclear. 

The  Subcommittee  on  Constitutional  Rights  has  long  been  interested 
in  psychological  testing  and  its  effects  on  constitutionally  guaranteed 
'civil  liberties  and  individual  privacy.   In  conjunction  with  this  interest, 
the  Subcommittee  has  been  surveying  the  entire  spectrvun  of  psychological 
testing  and  treatment. 


For  these  reasons,  I  would  like  to  obtain  information  concerning  the 
activities  to  be  carried  out  and  the  type  of  programs  to  be  utilized  at 
Butner  and  at  Springfield.   I  would  appreciate  your  response  to  the 
following  questions  so  that  the  Subcommittee  may  better- under stajid  the 
^purposes  of  these  projects. 

1.  Congress  has  appropriated  approximately  $20  million  for  develop- 
ment and  construction  of  the  Butner  facility.  Please  specify  all  types  of 
"treatment"  and  "research"  to  be  conducted  at  the  Butner  unit.  Please 
send  copies  of  all  pertinent  studies  and  plans,  including  plans  created 
*at  NUI  and  plans  for  programs  in  behavior  modification.  Please  send 
copies  of  all  programs  and  plans  of  study  proposed  under  Project  START. 


1007 


Mr.  Norman  A.  Carlson 
December  21,  1972 
Page  2 

2.  The  Butner,  North  Carolina  construction  was  introduced  as  peirt 
of  the  Bureau  of  Prisons'  plan  for  future  construction.  Please  specify 
hov/  this  unit  fits  into  the  long  term  goals  of  the  Bureau  and  aids  in  its 
programs,  and  include  copies  of  the  Bureau's  long  term  construction  plan. 
Are  there  any  plans  for  other  institutions  such  as  the  one  under  construction 
at  Butner  or  for  other  projects  such  as  START?  V/ill  results  at  Butner  and 
Springfield  be  made  available  for  state  use? 

3.  As  it  appears  that  there  will  be  research  from  outside  the 
facility  conducted  at  Butner  and  Springfield,  would  you  please  send  y3ur 
plan  for  the  type  of  review  process  and  screening  to  be  employed  at 
Butner  and  Springfield  for  acceptance  of  study  proposals.  Please  specify 
the  type  of  continuing  review  there  will  be  for  projects  in  progress, 

h.     The  inmates  at  Butner  and  at  Springfield  will  come  from  other 
units  around  the  country.  Please  send  copies  of  the  criteria  for  determining 
v/hich  prisoners  will  be  transferred  or  directly  incarcerated  at  Butner  and 
in  Project  START,  May  a  prisoner  refuse  to  be  admitted?  Inmates  at  Butner 
and  in  Project  START  will  be  segregated  from  the  other  prison  units  and 
will  require  records  inclusive  of  their  time  at  Butner  and  Springfield. 
Please  specify  what  records  will  exist  for  each  inmate  and  send  copies  of 
all  proposals  for  keeping  computerized  records.  Please  send  as  well  all 
proposals  for  keeping  psychological  data  in  gross  figures  or  by  individual 
case  studies.  Will  records  from  the  tvro  programs  be  integrated  with  other 
prison  records  for  each  prisoner?  What  type  of  access  will  exist  in 
relation  to  records  from  the  Butner  and  Springfield  facilities?  Who  will 
have  authorization  for  access?  Will  the  inmate  be  able  to  challenge  the 
accuracy  of  the  information  on  his  record  by  subsequent  psychological  tests? 
Please  supply  copies  of  the  Bureau's  proposals  in  this  area. 

5.  The  Butner  facility  and  Project  START  will  involve  treatment  as 
well  as  incarceration.  Please  specify  what  forms  of  experimentation  will 
be  allowed  and  what  controls  and  review  will  exist  for  experiments.   Please 
send  copies  of  proposals  for  employment  of  psychosurgery  or  psychotropic 
drugs  and  control  of  their  use.  Will  inmates  be  allowed  to  refuse  treatment 
or  request  transfer  after  admittance  to  Butner  or  Springfield? 

6.  The  programs  at  Butner  and  Springfield  seem  treatment  oriented. 
Please  send  copies  of  the  Bureau's  concept  of  incarceration  under  Project 
START  and  at  Butner--will  it  terminate  with  successful  treatment  or  at  the 
end  of  the  prescribed  sentence  period?  Will  a  prisoner  receive  good  time 
benefits  for  admittance  and  treatment  at  Butner  or  Springfield? 

7.  How  does  Project  START  relate  to  Attorney  General  Kleindienst's 
press  release  of  December  h,   1972,  which  discusses  the  Bureau  of  Prisons' 
10-year  program?  Please  send  copies  of  the  Bureau's  plans  for  therapy 
programs  in  its  10-yestr  plan. 


1008 


Mr.  Norman  A.  Carlson 
December  21,  1972 
Page  3 


Your  cooperation  in  this  matter  would  be  greatly  appreciated  and 
will  aid- in  the  Subcommittee's  efforts  to  preserve  individual  liberties. 

With  kindest  wishes, 

Sincerely  yours, 


OOvn  g?^^^'^  f  A^-   . 


Sam  J.  Ervin,  Jr. 
Chairman 


SJE:apm 


1009 


UNITED  STATES  DEPARTMENT  OF  JUSTICE 
BUREAU      OF      PRISONS 
WASHINGTON.  D.  C.  20537 

'^lii  1  2 1373 

omcB  or  THc  dirbctor 

February  8,    1973 


The  Honorable  Sam  J.    Ervin,   Jr. 

Chairman 

Subcommittee  on  Constitutional  Rights 

United  States  Senate 

Washington,   D.   C.     20510 

Dear  Senator  Ervin: 

Please  excuse  the  delay  in  responding  to  your  letter  of 
December  21,    1972,   requesting  information  concerning  programs  at 
the  new  Bureau  of  Prisons  facility  at  Butner,   North  Carolina  and  at 
the  Medical  Center  for  Federal  Prisoners  in  Springfield,   Missouri, 

Your  first  question  concerns  the  programs  to  be  established  at 
the  Butner  facility.     This  institution  will  serve  two  prime  functions. 
The  first  is  to  provide  psychiatric  services;  the  second  purpose  is  to 
develop  more  effective  correctional  treatment  programs. 

The  psychiatric  or  mental  health  program  at  Butner  will  be 
housed  in  three  units  separated  physically  from  the  remainder  of  the 
institution.     Federal  offenders  who  are  acutely  disturbed,   diagnosed 
suicidal  and  beyond  the  management  capabilities  of  regular  institutions, 
will  be  transferred  to  Butner  for  psychiatric  services.     This  will  alle- 
viate some  of  the  overwhelming  demands  for  psychiatric  services  which 
presently  exist  at  the  Medical  Center  for  Federal  Prisoners  -  the  single 
institution  designed  to  handle  this  type  of  offender.     The  type  of  pro- 
grams conducted  in  the  mental  health  units  will  be  comparable  to  those 
found  in  the  best  mental  health  facilities  in  communities.     The  proxim- 
ity to  three  universities  in  the  North  Carolina  area  will  bring  to  the 
Butner  facility  a  wide  variety  of  consultants  whose  expertise  will  help 
in  the  development  of  effective  methods  for  helping  these  inmates  to 
better  cope  with  their  emotional  problems. 

The  Butner  facility's  second  major  program  area  -  which  will 
be  housed  in  four  units  of  fifty  men  each  -  is  the  correctional  treatment 
program  section.     The  intent  here  is  to  develop  more  effective  methods 
for  the  retraining  and  rehabilitation  of  convicted  federal  offenders. 


1010 


Senator  Sam  J,   Ervin,    Jr. 
Page  2 


Programs  -will  be  devised  which  enable  individuals  to  better  cope  with 
the  demands  of  free  society.     Those  program  elements  which  appear 
to  be  successful  in  achieving  this  objective  will  be  made  known  to 
other  federal,    state,   and  local  correctional  institutions.     This  will 
help  them  upgrade  the  level  of  their  programs  and,   in  part,   contribute 
to  the  Bureau  of  Prisons'  effort  of   serving  as  a  model  for  the  nation's 
correctional  systems. 

In  the  last  portion  of  your  first  question  you  inquire  about 
project  START,     Enclosed  you  will  find  a  copy  of  the  Operations 
Memorandum  which  initiated  this  program.     Its  intent  is  to  provide 
additional  treatment  resources  for  individuals  Avho  appear  to  be  too 
difficult  to  manage  in  regular  institutions  but  who  are  not  diagnosed 
as  psychotic  when  they  are  interviewed  by  competent  mental  health 
staff.     In  order  to  avoid  the  poor  situation  in  which  these  people  are 
transferred  back  and  forth  between  institutions,   a  new  program  was 
devised  to  specifically  meet  their  needs.     This  is  housed  in  the  Medi- 
cal Center  at  Springfield,   Missioui;  it  has  been  established  as  a 
totally  separated  area.     That  is,  the  participants  in  the  START  pro- 
gram have  no  contact  with  the  psychiatric  patients.     They  have  their 
own  living  quarters,  work  area,   and  recreation  area. 

Your  second  question  asks  for  information  in  regard  to  the 
following:    Concerning  the  manner  in  which  the  Butner,   North 
Carolina  institution  fits  into  the  long  term  goals  of  the  Bureau, 
whether  there  are  plans  for  other  institutions  such  as  Butner,   or 
other  projects  such  as  START,  and  whether  the  results  from  these 
programs  will  be  made  available  to  the  states. 

The  Butner  institution  was  designed  as  a  one-of-a-kind  facility. 
The  concept  for  Butner  was  explained  during  the  course  of  Congres- 
sional hearings  on  the  appropriations.     In  addition  to  the  ten  year  con- 
struction plan,  please  find  enclosed  a  briefing  paper  on  this  facility. 
There  are  no  plans  for  other  institutions  similar  to  Butner.     However, 
you  will  note  in  the  ten  year  plan  that  there  are  institutions  designated 
to  serve  as  regional  psychiatric  hospitals;  these  have  a  more  narrow 
zmssion  than  Butner, 


1011 


Senator  Sam  J,   Ervin,   Jr. 
Page  3 


The  START  program  is  not  envisioned  as  being  expanded  to 
additional  institutions  since  it  also  serves  a  narrowly  defined  "border- 
line" population.     There  are  plans  to  develop  special  long-term 
control  programs  for  violent  and/or  dangerous  inmates  in  penitentiary- 
settings.     The  purpose  of  those  programs  will  be  to  provide  a  treat- 
ment alternative  for  inmates  who  require  very  close  control,     A  Policy 
Statement  detailing  the  standards  for  this  program  is  currently  being 
prepared. 

Program  evaluation  results  from  the  Butner  and  START 
programs  will  be  made  available  for  use  by  other  federal,   state,   or 
local  institutions.     One  of  the  unique  purposes  which  Butner  is  to 
serve  will  be  to  provide  information  for  all  correction  systems  in 
an  effort  to  make  correctional  treatment  programs  throughout  the 
country  more  effective. 

Your  third  question  concerns  the  review  process  and  screening 
for  research  proposals  for  projects  to  be  conducted  at  Butner  and 
Springfield.     Attached  you  will  find  a  copy  of  the  Bureau  of  Prisons 
Policy  Statement  on  research.     As  you  will  note,   the  final  approval 
for  all  research  projects  rests  in  the  hands  of  the  Director  of  the 
Bureau  of  Prisons,     Periodically,    reports  are  required  and  audits  of 
the  institution  programs  will  be  conducted  in  these  facilities  as  they 
are  throughout  the  federal  correctional  system.     We  are  very  much 
concerned  with  the  rights  of  individuals  who  are  participants  in 
research  projects.     Accordingly,  we  have  incorporated  into  our  poKcy 
statement  the  standards  which  emerged  from  the  Nuremberg  trials  and 
the  statement  of  the  Surgeon  General  regarding  investigations  involving 
human  subjects. 

Your  fourth  question  deals  with  concerns  involving  the  use  of 
records  and  the  naanner  in  which  inmates  will  be  transferred  into  the 
Butner  and  Springfield  facilities.     The  appended  Operations  Memoran- 
dum on  the  START  program  lists  the  criteria  for  selection.     Inmates 
are  not  permitted  to  refuse  transfer.     This  is  similar  to  the  instance 
in  which  inmates  are  not  permitted  to  refuse  being  transferred  to 
facilities  when  they  require  more  secure  control.     Procedural  safe- 
guards have  been  built  in  so  that  people  are  not  transferred  for 
"punishment"  reasons.     At  the  Butner  facility,  inmates  who  are 
transferred  to  the  psychiatric  section  will  not  be  permitted  to  refuse 
transfer.     An  effort  will  be  made  in  the  correctional  treatment  units 


1012 


Senator  Sam  J,   Ervin,   Jr. 
Page  4 


to  select  inmates  who  are  willing  to  participate  in  the  program  develop- 
ment effort.     However,   it  may  be  necessary  to  transfer  individuals  for 
whom  it  is  felt  the  new  program  would  most  appropriately  mieet  their 
treatment  needs. 

In  regards  to  record  security,  the  same  type  of  security  which 
exist  throughout  the  federal  system  concerning  access  to  information 
in  inmates  records  will  be  in  operation  at  Butner  and  Springfield. 
Psychological  data  collected  in  these  facilities  are  used  in  two  major 
ways.     They  are  used  initially  to  help  staff  members,   in  collaboration 
with  the  individual  inmate,   to  design  appropriate  treatment  programs. 
When  used  in  the  second  way  -  to  evaluate  program  success  -  these 
data  are  used  only  in  the  aggregate  and  do  not  identify  specific  inmates. 
Any  reports  emerging  from  these  studies  will  not  identify  inmates  and 
will  report  only  group  data.     In  regard  to  the  possibility  of  inmates 
challenging  data  contained  in  their  records,   it  is  possible  for  inmates 
to  request  and  receive  repeat  psychological  examinations. 

Question  five  poses  a  number  of  concerns  similar  to  those 
raised  in  question  three  in  regard  to  controls  over  experimentation. 
The  nature  of  the  "experiments"  will  be  in  the  area  of  program  develop- 
ment.    That  is,   methods  will  be  tried  to,   for  example,  help  timid, 
inferior-feeling,   inmates  gain  a  better  self  image  through  skill  develop- 
ment,   educational  attainment,   etc.     Psycho- surgery  will  not  be  used. 
Psychotropic  medication  will  be  used  only  in  the  mental  health  facility 
during  the  initial,   acutely  disturbed  phase  of  a  psychotic  patient's  treat- 
ment.    The  goal  here  will  be  to  have  the  patient  off  medication  and  fully 
participating  in  a  variety  of  treatment  modalities  which  will  be  made 
available  for  him.     Acutely  disturbed  inmates  will  not  be  permitted  to 
refuse  treatment.     Inmates  who  are  in  the  correctional  treatment  units 
can  refuse  treatment  and  this  then  becomes  part  of  the  program  evalua- 
tion process.     That  is,   if  a  program  is  implemented  in  which  many 
inmates  refuse  to  participate,  then,  this  suggeststhat  such  a  program 
is  not  effective.     Accordingly,   a  different  program  will  be  devised  - 
subject  to  the  review  procedures  as  outlined  in  the  Bureau  of  Prisons 
policy  stcitement. 

Question  six  is  concerned  with  the  Bureau  of  Prisons'  philosophy 
in  regard  to  incarceration  and  also  raises  questions  concerning  length 
of  confinement.     The  Bureau's  concept  of  incarceration  is  incorporated 
in  its  stated  mission:    Correction  of  the  Offender.     In  attempting  to 


1013 


Senator  Sam  J.   Ervin,   Jr. 
Page  5  \ 


achieve  this  goal,   individuals  committed  to  the  custody  of  the  Bureau 
of  Prisons  must  be  treated  humanely,   must  be  given  maximum  indi- 
vidual attention;  treatment  programs  must  be  developed  with  the 
inmate's  involvement  and  based  upon  the  individual's  needs.     Both 
Butner  and  START  are  designed  to  implement  this  philosophy. 

Neither  in  Butner  nor  START  are  any  inmates  kept  beyond  the 
length  of  their  prescribed  sentence.     Both  in  the  Butner  psychiatric 
program  and  in  START  inmates  are  returned  to  their  initial  institution 
following  the  end  of  a  successful  treatment  course.     Inmates  who  par- 
ticipate in  the  program  development  section  of  Butner  are  there  for  a 
prescribed  amount  of  time  -  tw^elve  to  eighteen  months  -  and  then 
returned  to  their  originating  institution.     Inmates  participating  in  these 
program  development  efforts  will  be  selected  so  that  their  expected 
release  time  will  be  beyond  the  project  date  of  completion.     However, 
should  an  inmate  become  eligible  for  a  parole,  he  will  be  released  and 
not  detained  solely  for  research  purposes, 

Goodtime  benefits  are  set  by  law  and  not  affected  by  the 
programs  operating  at  Butner  or  START.     Actually,  inmates  in  START 
are  afforded  an  opportvmity  to  earn  "industrial  goodtime"  which  many 
of  them  would  not  have  been  eligible  for  had  they  not  been  selected  for 
this  program. 

Question  seven  relates  to  the  manner  in  which  project  START 
relates  to  a  press  release  made  by  Attorney  General  Kleindienst  on 
December  4,    1972.     Attorney  General  Kleindienst  made  a  speech, 
rather  than  a  press  release,   on  December  4,    1972  to  judges  of  the 
courts  in  Washington,   D,   C,     In  that  speech  he  pledged  his  support 
for  the  Bureau's  ten  year  program  (a  copy  of  which  is  enclosed). 

The  Bureau's  plans  for  therapy  programs  in  the  next  ten  years 
are  general  rather  than  specific.     The  reason  for  this  is  the  rapid  rate 
of  change  which  is  occuring  not  only  in  corrections  but  in  all  of  the 
behavioral  and  social  sciences.     While  we  cannot  identify  specific  pro- 
grams for  the  entire  upcoming  ten  year  period,  we  do  know  that  the 
best  approaches  incorporate  the  following  concepts:    Differential  treat- 
ment of  inmates  in  which  programs  specific  to  meet  the  needs  of 
individual  inmates  will  be  made  available  on  a  "prescription"  like 
basis;  "normalizing"  institutions  so  that  the  detrimental  effects  of 


93-999  O  -  73  -  pt.  3  --  15 


1014 


Senator  Sam  J.    Ervin,   Jr. 
Page  6 


incarceration  are  minimized  and  inmates  learn  to  cope  with  problems 
in  situations  vrhich  as  close  as  possible  approximate  free  world  condi- 
tions; involvement  of  the  inmate  in  the  decision  making  process  so 
that  he  has  a  commitment  to  participate  in  programs  designed  to  help 
him  make  a  more  successful  free  world  adjustment;  greater  community 
involvement  which  will  help  enrich  the  program  alternatives  available 
to  inmates;  and  a  lessening  of  restraints  on  individual  freedom  whether 
in  institutional  or  community  based  programs. 

We  realize  this  reply  is  quite  lengthy.     However,   our  intent  was 
to  provide  you  with  comprehensive  information  concerning  the  ques- 
tions that  you  have  raised.     If  there  still  remains  a  need  for  further 
clarification,  please  do  not  hesitate  to  contact  this  office. 


Sincerely, 

Wrlson 


'/a 


Enclosures: 

1.  Policy  Statement  on  "Research" 

2.  Operations  Memo,    re:    "START" 

3.  Attorney  General  Kleindienst 

Press  Release 

4.  Ten  Year  Program 

5.  F.C.C.R.  White  Paper 


1015 


Federal  Center  for  Correctional  Research 
Federal  Bureau  of  Prisons 
Butner,  North  Carolina 
August  22,  1972 

The  Federal  Center  for  Correctional  Research  will  be  a  unique  facility 
in  the  Federal  correctional  system,  specializing  in  long-term  research  on 
the  treatment  and  management  of  various  types  of  offenders.   The  Center 
will  study  and  treat  selected  subgroups  of  offenders  in  an  attempt  to 
devise  effective  treatment  programs  which  can  be  adopted  by  other  cor- 
rectional facilities. 

The  "correctional  program  research"  units,  housing  about  190  persons, 
will  attempt  to  develop  programs  for  offenders,  such  as  minority  groups,  and 
subgroups  like  alcoholic  felons,  overly  passive  folloxi/er  types,  and  various 
other  groups.   These  inmates  will  be  at  Butner  for  a  period  of  intensive 
study  and  treatment  in  an  effort  to  determine  what  kind  of  correctional 
program  is  effective  with  each  type  of  offender.   A  system  for  monitoring 
results  during  the  treatment  period  will  be  devised  and  the  evaluations  of 
these  studies  will  be  published. 

A  "mental  health  research"  program  will  care  for  a  population  of  about 
35  young  men,  35  women,  and  60  adult  men  who  are  in  the  acute  phase  of  mental 
disturbance.   The  objective  of  the  research  program  will  be  to  develop  and 
implement  intensive  treatment  approaches  for  mentally  disturbed  patients  who 
constitute  a  management  problem.   The  treatment  effort  will  attempt  to  stabi- 
lize these  special  cases  so  they  can  be  returned  as  quickly  as  possible  to 
the  sending  institution  to  resume  their  correctional  treatment. 

Various  treatment  approaches  will  be  used  in  the  semi -autonomous  housing 
units  including  group  therapy,  individual  counseling,  specialized  education, 
vocational  programs,  social  services  and  leisure- time  activities.   However, 
shared  activities  will  be  provided  in  a  central  area-small  chapel,  canteen, 
.dining  hall,  indoor  and  outdoor  recreation,  auditorium  and  clinic.   This 
"Community  Green"  will  resemble  a  to\m.   center  where  residents  and  visitors 
can  associate  in  an  atmosphere  as  normalized  as  possible. 

The  location  of  the  Center  makes  possible  a  close  working  relationship 
with  the  medical  schools  and  universities  in  the  Raleigh-Durham-Chapel  Hill 
"Research  Triangle"  area.   Staff  members  of  these  organizations,  as  well  as 
representatives  of  the  National  Institute  of  Mental  Health,  the  Department 
of  Health,  Education,  and  Welfare,  and  the  National  and  North  Carolina 
Advisory  Panels  to  the  Bureau  of  Prisons  have  assisted  the  Bureau  planning 
staff  in  developing  the  programs  and  architectural  design  for  the  facility. 

Instead  of  a  traditional  institution,  the  facility  will  have  a  more 
psychologically  pleasing  character,  designed  to  be  adaptable  to  changing 
research  procedures.   Rather  than  guard  towers,  underground  electronic 
detection  systems  together  with  a  mobile  vehicular  patrol  will  be  used 
for  more  effective  perimeter  security.   Special  windows  of  a  special 
plastic  and  glass  laminate  with  a  built  in  alarm  will  furnish  better  and 
more  economical  security  as  well  as  providing  a  better  therapeutic  environ- 
ment. 


1016 


The  architectural  firm  is  Middleton,  Wilkerson,  McMillan  of  Charlotte, 
North  Carolina,  who  will  also  provide  construction  management  services  for 
the  project. 


Capacity;      Mental  Health  Research 

38  Youth  -  Male 
64  Adult  -  Male 
38  Female 

Correctional  Research 

200 

Maintenance  Cadre 

40 

Infirmary 

8 


388  TOTAL  BEDS 

Square  Footage:  235,000 

Area  Inside  Fence:  42  Acres 

Construction  Start:  June  1972 

Construction  Finish:  February  1974 


1017 


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1018 


Operations  Memorandum  1  7300.128 


10-25-72 


Sl)3JZCT:  PROCEDURE  FOR  PROCESSING  PARTICIPANTS  INTO 
PROJECT  START  (SPECIAL  TREATMENT  AND  . 
REHABILITATIVE  TRAINING)  .-/- 

1.  PURPOSE  _^ 

a.  To  provide  the  criteria,  for  selection  of  ixmates  for  participation 
in  Project  START. 

b.  To  transmit  procedures  for  processing  inmates  from  home  institution 
to  Project  START.  ^' 

2.  BACKGROUND.   In  an  attempt  to  develop  behavioral  and  attitudinal 

changes  in  offenders  who  have  not  adjusted  satisfactorily 
to  institutional  settings,  the  Bureau  has  recently  initiated  a  Special 
Treatment  and  Rehabilitative  Training  (START)  Program  at  Springfield. 
The  Program  is  designed  to  provide  care,  custody,  and  correction  of  the 
long  term  adult,  offender  in  a  setting  separated  from  his  home  institution. 

3.  SELECTION  CRITERIA.  The  START  Program  will  be  for  30-35  inmates  and 

those  who  complete  the  program  will  not  be  eligible 
for  return  to  START.  When  an  institution  is  screening  an  inmate  for 
participation  in  the  program,  it  is  necessary  that  the  inmate  meet  the 
following  selection  criteria: 

(a)  Will  have  shown  repeated  inability  to  adjust  to  regular  institu- 
tional programs-~not  just  minor  offenses. 

(b)  Will  be  transferred  from  the  sending  institution's  segregation 
unit . . 

(c)  Generally,  will  have  a  minimum  of  two  years  remaining  on-his 
sentence.. 

(d)  Will  not  be  overtly  psychotic  (overtly  psychotic  iimiates  are 
appropriate  referrals  to  the  regular  medical  center  psychiatric 
program  ">  * 

(e)  Will  have  had  experience  in  an  adult  penitentiary. 

(f)  Will  not  be  a  continuous  escape  risk,  and  in  terms  of  personality 
characteristics,  shall  be  aggressive,  manipulative,  resistive 

to  authority,  etc. 

4.  REFERRAL  PROCEDURES.   Institutions  wishing  to  refer  inmates  to  START 

will  request  transfer  authorization  from  the 
Office  of  the  Coordinator  of  Mental  Health  Services.  This  request, 
submitted  by  the  Warden,  should  contain  a  thorough  narrative  justification 
supporting  such  a  transfer  and  docromenting  how  an  inmate  fulfills  selection 
criteria. 


1019 


7300.128 
10-25-72 


All  transfers,  in  and  out  of  this  program,  will  go  through  the  Office  of 
the  Coordinator  of  Mental  Health  Services. 


5.   THIS  OPERATIONS  MEMORANDUM  IS -CANCELLED  EFFECTIVE  OCTOBER  31,  1973. 


/  W>^v*^-v^  6^  ^^^*''^*t^e><^ 


NORMAN  A.  CARLSON 

Director 

Bureau  of  Prisons 


1020 


I 


JAMES  1-.  KASTVANO,  MISS.,  CHAIRMAN  I            ^                                               .             ,      SUOCOMMITTCCl 

JOHN  l„  MCCLCLUAN,  ARK.                    ROMAN  U.  HRUSKA,  NEBR.  ^                                             SAM  J.  ERVIN,  JR..NX.,  OIAIRMAN 

fJ'.^'.-f^L''-,.-"':,'''''-                             HIRAM  U  FONO.  HAWAII  JOHN  L.  MC  CLEUJkN.  ARK.                                ROMAN  L.  HRUSKA.  NEW 

^^i:    o^                 •      J"-^...               ""°"  SCOTT.  PA.  EDWARO  M.  KENNEDY,  MASS.                           HIRAM  U.  FONO.  HA«  ^ 
EOWARO  M.  KENNEDY,  MASS.              STROM  THURMOND,  SX, 

"~  JOHN  V,  TUNNIY,  CAUP, 


_  _.      _,  BIRCH  BAYH.  INO,  STROM  THURMOND,  •«. 

BIRCH  BAYH.  IND.  MARLOW  W.  COOK.  KY,  BoarjrT  C    BYBO    W    WA  HUOM  BCOTT    FA.  — 

OUENTIN  N.  BU.*OICK,  N.  DAK.  CHARUES  MCC.  MATHIAS,  JR,.  MD.  ROBERT  C.  BYHO,  W.  VA.  HUOH  SCOTT,  PA.  ■ 

ROBERT  C.  DYRO,  W.VA.  COWARD  J.  QURNCY,  FLA. 

JOHN  V.  TUNNCY,  CAUF. 


QlCniicb  /Sfaics  JS>2na{Q 

COMM ITTEE  ON  THE  JUDICIARY 

SUBCOMMITTEe  ON  CONSTITUTIONAL  RIGHTS 

(pursuant  TO  SEC.  I,  B.  RCS.  IM,  ttO  CONORU*) 

WASHINGTON.  O.C.     20510  ' 

February  23,   1973  j 

Mr.  Jlorman  A.  Coxison 
Director 

U.S.   Bureau  of  Prisons 
Dcpartnient  of  Justice 
'  Uashin^tpa,  D.C. 

Dear  Mr.   Carlson: 

Thank  you  for  your  I'eply  of  February  8,    1973j    to  our  letter  inquiring 
into  the  progrcuns  at  Butner,   Ilorth  Carolina,   and  Springfield,  Missouri, 
'concerning  behavior  modification  programs.     The  information  was  most  helpful 
and  answered  meuny  questions  that  were  still  open  in  my  mind. 

There  are   several  questions  v;hich  I  hope  you  vrould  be  kind  enough  to 
respond  to  in  this  area.     The  information  desired  concerns  various  points 
not  ansv/ered  in  your  letter  and  some  additional  points  v;hich  I  would 
■appreciate  your  clarifying. 

In  relation  to  the  Butner  facility,   I  vrould  like  to   inquire  as  to  v;hat 
specific  forms  of  assurances  are  provided  to  control  punitive  transfers. 
As  you  mentioned  in  your  letter,   such  controls  exist  and  I  would  appreciate 
a  copy  of  them.     You  note  that  all  projects  will  confoi-ra  to  established 
medical  standards  in  relation  to  human  experimentation.      I  vA^uld  like  to 
knov;  to  v;hat  degree  prograois   created  at  the  National  Institutes  of  Health 
or  National  Institute  of  Mental  Health  v/ill  be  amployed.      I  would  also   like 
to   ;:now  the  degree  to  which  the  peer  revievf  type  process  employed  at  NIH 
v;lll  be  utilized  at  Butner.      I  note   that  the  Director  of  the  Bureau  of 
Prisons  v;ill  have  final  approval  authority  over  all  projects  conducted  at 
Butner  in  the  Correctional  Program  Development  Unit.      Hov?  v;ill  this  final 
authority  relate  to  recornmendations  made  by  NIK,   universities  or  peer 
reviev/  committees? 

In  relation   co  Project  ST/xRT,    v/ould  you  please  send  information  concerning 

the  actual  programs  involved  in  the  treatment  of  initiates  at  Springfield. 

Further;nore,    I  v;ould  like   to   knov/  if  Project  START  is   to  be   terminated  at 

the  end  of  its  operations  memorandum  date  of  October  yi,  1973;   or  if  it  will 
be  continued  beyond  that  date. 


N 


1021 


I-lr.  Norman  A,  Carlson 
February  23,  I973 
Pase  2 


I  would  also  like  to  loiow  if  the  Bureau  has  any  plans,  either  at 
Butner  and  Springfield  or  elsev.'here,  for  prograins  involving  treatment  of 
homosexuals.  Does  the  Bureau  have  plajis  for  the  treatment  of  sexual 
offenders  or  homosexuals  in  behavior  modification  programs?  I  would 
appreciate  a  copy  of  Euiy  such  programs. 

I  thank  you  for  your  cooperation  in  clarifying  these  matters  which 
are  of  concern  to  all  citizens  of  the  United  States.  The  protection  of 
individual  privacy  and  the  provision  of  informed  consent  for  every  individual 
participating  in  experimental  programs  are  basic  guarantees  of  individiial 
rights,  which  I  am  sure  you  will  agree  must  be  preserved. 

Again,  my  appreciation  for  your  first  response  ajid  I  hope  this  inq.uiry 
will  not  inconvenience  you. 

VJith  kindest  wishes , 

Sincerely  yours, 


^5)0^  ^^^^a.uiv-1^  y 


Sam  J.  Ervin,  Jr. 
Chairman 


SJE:apm 


1022 


I 


UNITED   STATES   D:£PART.V.»iNT   OF  JUSTICE 

BUREAU       OF       PRJSONS 

Washington  20537 


March  23,    1973 

SAM  J.  ERVlf^^  jfj. 
Honorable  Sam  J.    Ervin,   Jr.  iMj  ■      ,,, 

-  -  '^  MAR  2  7 1973 

Washington,   D.    C.      20510  L- 

-•©ETrrrnT; 

Dear  Senator  Ervin:  ..,       — '^  i-;  L_Ji 

WASHINGTON,  D.C.  20510 
We  have  your  recent  letter  in  which  you  request  additional 
information  concerning  the  programs  at  Butner ,  North  Carolina  and  Spring- 
field, Missouri,  Your  first  question  relating  to  the  Butner  facility 
inquires  about  procedures  to  control  punitive  transfers.   Transfers  to 
the  3utner  facility  will  be  for  two  basic  purposes:   to  participate  in 
the  Mental  Health  Program;  and  to  participate  in  the  Correctional  Treatment 
Program  Section.   Before  an  inmate  will  be  transferred  for  psychiatric 
purposes,  he  will  have  been  evaluated  by  a  professional  mental  health 
person  at  the  sending  institution.   The  basis  for  his  transfer  will  be 
acute  psychiatric  disturbance  and/or  chronic  suicidal  attempts.  Upon 
receipt  ac  Butner,  the  patient  will  be  examined  by  the  Butner  staff 
relative  to  these  areas  of  concern.   Concurrence  by  the  Butner  staff 
will  be  necessary  before  the  patient  is  admitted  into  the  psychiatric 
facility.   In  regard  to  the  Correctional  Treatment  Section,  an  effort 
will  be  made  to  select  inmates  who  are  willing  to  participate  in  the 
program  development  effort.  However,  it  may  be  necessary  to  transfer 
individuals  for  whom  it  is  felt  that  the  new  program  would  most  appro- 
priately meet  their  treatment  needs.   Therefore,  it  will  be  the  treatment 
needs  of  the  individual  which  are  the  determinants  of  whether  or  not  he 
is  selected  for  placement  in  a  program.   Transfer  will  then,  not  be  for 
punitive  reasons  but  for  positive  treatment  benefit. 

The  controls  mentioned  which  currently  exist  were  stated  in 
reference  to  the  START  program.   These  are  contained  in  the  operations 
memorandum  which  was  sent  to  your  office.   They  refer  to  the  review 
procedure  which  takes  place  at  the  institution  by  the  inmate's  treatment 
team,  a  further  review  by  the  Warden,  and  a  final  review  by  a  member  of 
the  Central  Office  staff  before  an  inmate  is  selected  for  placement  into 
the  START  program. 

In  regard  to  your  question  concerning  the  degree  to  which     ■ 
programs  created  at  the  National  Institutes  of  Health  or  the  National 
Institute  of  Mental  Health  will  be  employed  at  Butner,  I  can  give  you  the 


1023 


Honorable  Sam  J,  Ervin,  Jr.  -  2  - 


following  information.   It  is  intended  that  there  will  be  a  collaboration 
between  governmental  agencies  in  regard  to  the  research  findings  of 
programs  conducted  within  each  jurisdiction.   Programs  conducted  under 
NIMH  grants  may  provide  leads  for  program  development  at  the  Butner 
facility.  However,  the  conducting  of  these  projects  will  be  entirely 
within  the  domain  of  the  Department  of  Justice.   The  review  procedure 
for  projects  of  this  nature,  as  spelled  out  in  the  research  protocol 
sent  to  your  office  with  the  previous  letter,  details  the  review  procedures 
prior  to  the  implementation  of  any  research  project  within  the  Bureau 
of  Prisons.   Recommendations  made  by  NIH,  universities  or  peer  review 
committees  in  regard  to  the  implementation  of  research  programs  will 
be  included  among  the  material  reviewed  by  the  Bureau  of  Prisons 
Rearch  Advisory  group.   This  group  consists  of  the  Assistant  Directors 
who  make  a  final  recommendation  to  the  Director  of  the  Bureau  of  Prisons. 
All  projects  require  approval  by  the  Director  before  they  can  be  imple- 
mented. 

In  regard  to  project  START,  you  will  find  enclosed  a  description 
of  the  program.   Prior  to  the  October  31st,  1973  date,  an  assessment  will 
be  made  of  project  START  in  regard  to  its  continuation  or  termination. 
At  that  time,  if  it  is  decided  to  continue  START,  a  formal  policy  state- 
ment will  be  written  outlining  the  procedures  and  guidelines  to  be  follow-, 
ed.         ■ 

t         We  have  developed  no  plans  to  implement  programs  which  are 
directed  specifically  at  the  treatment  of  homosexuals. 

We  would  certainly  agree  with  you  and  are  equally  concerned 
that  programs  which  we  developed  do  not  contravene  individual  privacy 
or  basic  human  rights.  We  trust  that  you  will  find  the  above  material 
responsive  to  your  request  for  additional  information.   If  there  are 
areas  which  require  further  clarification,  please  do  not  hesitate  to 
contact  this  office. 

Sincerely, 


NORMAN  A.  CARLSON 
Director 


Enclosure 


1024 

Senator  Kennedy.  The  committee  will  stand  adjourned  until  9:30 
tomorrow  morning  when  it  will  meet  in  room  4232  of  the  Dirksen 
Senate  Office  Building. 

[Whereupon,  at  1  p.m.,  the  subcommittee  recessed,  to  reconvene 
at  9 :30  o'clock  a.m.,  Thursday,  March  8, 1973.] 


I 


QUALITY  OF  HEALTH  CARE— HUMAN 
EXPERIMENTATION,  1973 


THURSDAY,   MARCH  8,    1973 

U.S.  Senate, 
Subcommittee  on  Health  of  the 

COMMFTTEE   ON    LaBOR   AND    PuBLIC   WELFARE, 

Washington^  D.C. 

The  subcommittee  met  at  9:30  a.m.,  pursuant  to  recess,  in  room 
4232,  Dirksen  Senate  Office  Building,  Senator  Edward  M.  Kennedy 
(chairman  of  the  subcommittee)  presiding. 

Present :  Senators  Kennedy  and  Mondale. 

Committee  staff  members  present :  LeRoy  G.  Goldman,  professional 
staff  member,  and  Jay  B.  Cutler,  minority  counsel. 

Senator  Kennedy.  The  subcommittee  will  come  to  order. 
•    Today  we  will  conclude  these  oversight  hearings  on  the  quality  of 
medical  care,  including  experimentation.  We  have  seen  many  signifi- 
cant problems  these  past  two  weeks,  problems  which  stem  in  large  part 
from  the  absence  of  quality  controls  in  the  practice  of  medicine. 

We  have  seen  that  physicians  can  and  do  prescribe  drugs  for  experi- 
mental purposes  with  no  supervision,  that  physicians  can  and  do  per- 
form experimental  surgical  procedures  on  the  basis  of  their  own  in- 
dividual judgments. 

Physicians  can  and  do  use  experimental  medical  devices  that  have 
never  been  proven  safe  and  effective,  and  we  have  seen  the  patients 
suffer  from  this  laissez  faire  system.  Serious  concern  was  expressed 
about  these  problems  by  the  Commissioner  of  the  Food  and  Drug  Ad- 
ministration, by  the  Director  of  the  NIMH,  by  the  Acting  Director  of 
NIH,  by  the  Acting  Administrator  of  the  Health  Sciences  and  Mental 
Health  Administration. 

I  can  see  little  of  more  importance  for  the  protection  of  the  health 
of  the  American  people  than  the  prompt  resolution  of  these  problems ; 
that  is  why  I  asked  Secretary  Weinberger  to  appear  today  to  present 
the  Administration's  policy  and  view  on  these  subjects.  These  problems 
transcend  individual  agencies  and  regrettably  there  is  no  Assistant 
Secretary  for  Health  at  HEW  to  testify.  In  fact,  two  of  the  three 
major  health  agencies  in  HEW  currently  have  Acting  Directors.  Yet 
Secretary  Weinberger  has  refused  to  appear. 

In  testimony  in  respect  to  his  confirmation  as  Secretary  of  HEW 
before  the  Finance  Committee,  Secretary  Weinberger  stated,  "To  the 
best  of  my  knowledge  I  have  never  declined  any  invitation  of  a  con- 
gressional committee  or  subcommittee  and  I  wovdd  give  that  the  very 
highest  priority." 

(1025) 


1026 

We  all  know  that  there  are  times  when  schedule  conflicts  make  an 
appearance  on  a  given  day  impossible.  Secretary  Weinberger  was 
given  great  latitude  to  find  a  date  and  he  still  refused.  I  repeat  my 
invitation  here  today  for  him  to  appear  at  a  time  of  mutual  conven- 
ience to  personally  address  these  issues. 

We  will  now  receive  for  the  record  a  statement  from  Senator  Ervin 
of  North  Carolina. 

STATEMENT  OF  HON.  SAM  J.  ERVIN,  JR.,  A  U.S.  SENATOR  FROM 

NORTH  CAROLINA 

Senator  Ervix.  I  wish  to  thank  the  Subcommitee  and  the  chairman, 
Senator  Kennedy,  for  this  opportunity  to  submit  a  statement  for  the 
record  of  the  Subcommittee  on  Health's  hearings  on  biomedical  re- 
search and  human  experimentation. 

The  Subcommittee  deserves  a  good  deal  of  praise  for  the  work  it  is 
doing  in  this  area  and  for  the  large  number  of  important  public  issues 
raised  in  these  hearings.  The  questions  surrounding  control  of  the  uses 
of  scientific  knowledge  constitute  a  most  complex  and  serious  problem. 
We  must  always  make  a  conscientious  effort  to  avoid  curtailing  the 
freedom  of  scientific  inquiry  necessary  to  expand  the  boundaries  of 
human  knowledge.  The  freedom  of  science  to  work  and  explore  by 
orderly  research  has  long  been  a  boon  to  our  American  way  of  life  and 
we  have  benefitted  enormously  by  that  research  intechnological  and 
medical  achievements  which  have  outpaced  the  rest  of  the  world. 

These  hearings  have  come  at  an  opportunite  time  for,  after  fifty 
years  of  scientific  research  and  experimentation  in  laboratory  settings, 
we  have  reached  a  breakthrough  in  the  biological  sciences  that  may 
promise  a  more  disease-free  and  healthly  life  for  all  citizens.  Experi- 
mentation and  treatment  now  have  turned  their  focus  from  the  labo- 
ratory to  human  subjects.  In  the  face  of  this  application  of  scientific 
methods,  we  cannot  allow  individual  rights  to  be  endangered  or  lost 
because  of  a  blinding  faith  in  science  and  medicine.  Constitutional 
safeguards  must  be  assured  at  the  same  time  that  government  funding 
nurtures  scientific  research  and  medical  treatment. 

Many  research  projects  involve  experimental  therapies  which,  even 
in  a  clinical  setting,  pose  threats  to  constitutional  rights.  These 
therapies  may  be  dangerous  when  either  by  their  mode  of  application 
or  by  the  very  nature  of  the  therapy  itself,  they  impinge  on  individual 
liberties.  If  a  therapeutic  method  is  to  be  imposed  on  a  patient  with- 
out his  consent  or  as  a  punishment,  then  the  therapy  is  not  necessarily 
at  fault  but  the  method  is.  On  the  other  hand,  if  a  party  consents  to 
the  application  of  a  therapeutic  method  which  either  he  or  his  phy- 
sician does  not  fully  understand  or  which  will  unalterably  affect  his 
life,  then  the  therapy  itself  may  pose  a  threat  to  individual  rights. 

In  light  of  these  problems  and  the  threats  to  cherished  freedoms 
which  may  be  created  by  certain  scientific  experiments  or  medical 
treatment,  I  wish  to  commend  the  Health  Subcommittee  for  its  fore- 
sight in  this  matter  by  calling  for  hearings  which  allow  an  airing  of 
the  matters  involved  prior  to  the  funding  of  further  research.  We  must 
strengthen  the  means  by  which  Congress  is  informed  of  scientific  pro- 
grams affecting  individual  rights  before  federal  money  is  used  to  sup- 
port such  research.  Whatever  legislation  is  recommended  by  the  Sub- 


1027 

committee-  I  hope  it  will  include  a  requirement  of  disclosure  and  re- 
view by  Congress  before  federal  financing  can  be  granted. 

My  experience  in  this  area  has  taken  me  through  several  years  of 
hearings  on  the  various  threats  to  individual  liberties  posed  by  govern- 
mental invasions  of  privacy.  The  Subcommittee  on  Constitutional 
Eights  has  been  psychological  tests  and  other  methods  used  to  attempt 
to  develop  classification  systems  for  our  citizens.  We  have  seen  sen- 
sitivity training,  polygraphs  and  the  growth  of  federal  and  private 
data  banks  threaten  the  security  of  the  individual  and  impose  on  his 
dignity.  We  have  seen  government  monitoring  of  the  activities  of  Con- 
gress and  military  surveillance  of  our  citizens. 

So  far  there  is  no  national  identification  system.  A  citizen  may  still 
enter  a  store,  present  a  credit  card,  and  know  that  his  entire  past  is  not 
available  to  a  store  clerk  by  the  flick  of  a  switch.  But  the  time  may 
soon  come  when  this  is  no  longer  true.  Already  state,  federal  and  pri- 
vate data  banks  are  being  created  which  collect  large  amounts  of  data 
on  individuals,  data  of  often  dubious  accuracy  and  relevancy,  but  data 
which  is  instantaneously  available  across  the  country.  Already  work 
is  being  done  on  a  universal  identifier  so  that  every  person  can  be 
numbered,  and  then  catalogued  by  that  number.  Already  work  is  in 
progress  on  a  single  universal  identification  card  to  replace  the  dozens 
of  credit  cards,  memberships,  licenses,  and  IDs  in  a  citizen's  pocket. 
As  the  chairman  knows,  the  problems  being  studied  by  the  Con- 
stitutional Eights  Subcommittee  are  fundamentally  the  same  as  those 
before  this  subcommittee.  That  is  why  I  wish  to  present  some  of  the 
information  we  have  gathered  for  your  consideration. 

I  would  like  first  to  discuss  a  problem  which  I  believe  has  reached 
the  critical  stage  today  in  the  area  of  scientific  experimentation  and 
treatment — federal  funding  for  behavior  modification.  The  chaos 
which  exists  in  this  field  is  partly  due  to  a  lack  of  control,  a  lack  of 
review  and  a  lack  of  interest  on  the  part  of  the  Congress.  I  believe 
there  are  serious  constitutional  problems  when  federal  funding  is 
doled  out  unchecked  for  behavior  modification  projects. 

Behavior  modification  involves  psychological  techniques  applied  as 
treatment  for  behavioral  problems.  Behavior  modification  attempts 
to  alter  or  change  the  attitudes  and  actions  of  a  person;  it  does  not 
seek  to  cure  the  behavioral  illness  but  rather  to  change  the  behavior. 
Behavior  modification  may  involve  relatively  mild  methods  such  as 
individual  or  group  therapy  as  well  as  more  persuasive  and  more  per- 
manent methods  as,  for  example,  operant  conditioning  (reward/ 
punishment  concepts).  Whatever  questions  exist  with  respect  to  these 
methods,  behavior  modification  today  has  an  even  larger  arsenal  of 
methods  to  draw  upon  than  ever  before,  and  these  other  techniques 
present  critical  issues  for  individual  rights.  Drugs  can  be  used  to  pun- 
ish and  thereby  secure  a  desired  behavior  (aversive  therapy).  They 
can  also  blunt  certain  emotions  (tranquilizers  and  psychoactive 
drugs).  Shock  therapies  can  jolt  the  memory.  Finally,  the  physical 
brain  itself  is  subject  to  alteration  by  surgical  or  drug  means.  Behavior 
modification  ranges  from  rewarding  school  children  with  gold  stars 
to  punishing  prisoners  with  drugs  that  simulate  Parkinson's  Disease 
or  cause  convulsions.  Naturally,  it  is  not  easy  to  decide  which  type  of 
behavior  modification  programs  are  dangerous  to  constitutional 
liberties  and  which  are  not.  I  would  like,  however,  to  deal  with  three 


1028 

separate  cases  where  abuse  has  occurred  or  possibly  is  occurring  and 
where  the  federal  government  has  a  responsibility  for  the  preservation 
of  individual  rights  and  the  prevention  of  injury  to  our  citizens. 

One  of  the  most  flagrant  examples  of  a  lack  of  congressional  control 
and  oversight  in  the  area  of  behavior  modification  came  during  the 
past  fiscal  year.  In  1971  a  program  was  begun  at  Boston  City  Hospital 
by  Dr.  William  Sweet,  one  of  the  world's  leading  neurosurgeons,  to 
explore  violent  'behavior.  The  project  was  funded  by  a  $500,000  grant 
from  NIMH.  The  project  employed  various  means  of  studying  and 
treating  violent  behavior ;  among  these  methods  were  the  implantation 
of  electronic  devices  in  the  brain,  the  use  of  massive  drug  doses 
which  can  permanently  affect  behavior,  and  psychosurgery.  The  goal 
of  the  program  was  to  develop  psychological  tests  to  identify  violent 
behavior  and  develop  treatment  methods.  The  project  was  so  con- 
troversial that  the  first  hospital  approached,  Massachusetts  General 
Hospital,  refused  the  grant. 

At  the  same  time  as  this  NIMH  project  was  going  on,  some  of  the 
doctors  from  the  project  were  working  on  a  similar  behavior  research 
project  funded  by  the  Law  Enforcement  Assistance  Administration. 
This  project  was  intended  to  develop  a  classification  system  to  identify 
a  tendency  for  violence  among  prisoners.  This  project,  conducted  at  a 
federal  male  prison  and  a  female  multi-state  prison,  was  terminated 
early  due  to  funding  abuses  arising  within  the  project.  Neither  project 
has  submitted  a  completed  report,  and  neither  project  has  submitted 
a  summary  of  its  activities  that  show  any  conclusive  evidence  of  suc- 
cess or  rationale  for  further  funding.  Yet,  in  hearings  before  the  Sen- 
ate xVppropriations  Committee,  Dr.  Sweet  testified  that  the  work  had 
been  successful  in  Boston  and  at  the  prisons.  Dr.  Sweet  also  stated  that 
one  million  dollars  was  desired,  under  the  auspices  of  NIH,  for  further 
work  and  expansion  of  the  project  at  Boston  City  General. 

It  was  only  at  the  last  minute  that  Senator  Magnuson  addressed  a 
letter  to  Director  Marston  of  NIH  urjjins:  caution  and  care  in  further 
funding  of  violent  behavior  research.  Dr.  Marston  replied  stating 
that  NIH  would  make  the  greatest  efforts  to  safeguard  individual 
rights.  In  response  to  letters  from  the  Subcommittee  on  Constitutional 
Rights,  former  Secretary  of  Health,  Education  and  Welfare  Elliot 
Richardson  and  Secretary  Caspar  Weinberger  have  promised  that  re- 
porting would  be  made  to  Subcommittee  on  any  funding  by  HEW  for 
behavioral  research  involving  violent  behavior  studies.  Copies  of  the 
correspondence  dealing  with  the  NIH  funding  and  from  HEW  are 
attached  to  my  statement. 

Now  it  should  be  obvious  that  programs  which  aim  at  typing  cer- 
tain citizens  as  "violence  prone"  raise  serious  problems  of  individual 
rights.  The  issue  is  no  less  and  no  different  from  a  government  pro- 
gram of  labelling  individuals  as  "radicals,"  "subversives,"  or  "Com- 
munists." Certainly  before  any  such  project  is  funded  by  Congress, 
those  problems  should  be  exhaustively  considered.  They  never  were 
when  these  first  grants  were  approved. 

The  absence  of  congressional  inquiry  and  of  congressional  oversight 
allowed  an  NIMH  project  to  submit  individuals  to  what  many  regard 
as  inhuman  and  degrading  abuse  by  physicians.  Projects  which  in- 
volve experimental  techniques  or  techniques  which  sharply  curtail 
an  individuals'  independence  and  freedom  of  thought  deserve  the 


1029 

utmost  concern  on  the  part  of  the  Congress.  Reporting  of  projects  such 
as  those  funded  by  LEAA  and  NIMH  would  have  allowed  de'bate 
and  review  by  the  Congress.  No  such  programs  should  be  funded 
by  NIMH  or  any  government  agency  unless  and  until  the  closest 
scrutiny  is  given  to  them. 

Prisons  exist  as  a  closed  society,  eluding  the  public  eye  behind  high 
walls  and  restricted  contact.  Only  recently  has  there  been  any  interest 
in  assuring  prisoners  the  benefits  of  those  constitutional  rights  which 
follow  them  into  the  prison  or  jail.  Only  in  the  last  decade  have  court 
decisions  sought  to  insure  the  rights  to  counsel,  legal  materials,  cor- 
respondence and  of  freedom  from  cruel  punishment.  Testimony  be- 
fore the  Health  Subcommittee  has  revealed  that  in  the  coercive  at- 
mosphere of  a  prison,  inmates  are  more  than  willing  to  submit  to  drug 
experiments  and  other  experimental  programs  in  order  to  secure 
money  or  a  change  of  location  and  conditions  or  to  please  the  parole 
board  by  a  record  showing  cooperation  with  the  prison  authority.  The 
use  of  behavior  modification  in  such  a  setting  poses  serious  threats  to 
constitutional  liberties.  Behavior  modification  is  not  simply  an  experi- 
mental concept.  It  is  a  treatment  to  which  a  prisoner  is  asked  or  or- 
dered to  submit. 

There  has  been  no  definitive  court  case  involving  behavior  modifica- 
tion in  the  prisons ;  however,  cases  are  now  pending  before  the  courts. 
One  case  in  California  is  challenging  aversive  conditioning  therapy 
which  employs  a  drug  known  as  anectine  to  produce  respiratory  con- 
vulsions. Cases  dealing  with  medical  treatment  in  prisons  have  dealt 
primarily  with  allegations  of  malpractice  and  negligence  in  treatment 
or  with  the  administration  of  drugs- which-produce-in jury  civil  suits. 
Most  courts  have  rejected  complaints  alleging  unauthorized  uses  of 
drugs  as  punishments. 

To  understand  the  Bureau's  attitude  toward  treatment  of  its  men- 
tally disturbed  offenders,  the  following  statements  by  Director  Nor- 
man Carlson  are  of  note  as  a  preface  to  the  discussion  that  will  follow. 
Speaking  before  the  Subcommittee  on  National  Penitentiaries  [Fu- 
ture Role  of  the  U.S.  Bureau  of  Prisons  (92nd  Cong.,  2nd  Sess.)], 
Director  Carlson  noted  the  Bureau's  attitude  toward  mentally  ill  of- 
fenders and  the  need  for  treatment  by  the  government. 

*  *  *  nearly  20  percent  of  all  offenders  committed  to  our  custody  suffer  from 
some  type  of  mental  disorder,  not  necessarily  psychotic,  but  certainly  present 
mental  illness.  It  is  a  fact  which  we  have  long  been  aware  of  and  I  think  Butner 
is  going  to  be  a  facility  which  will  certainly  enhance  our  capabilities  to  work 
with  this  type  of  population. 

In  later  testimony  before  the  same  subcommittee,  in  June  of  1972, 
the  Director  indicated  what  might  be  the  major  factors  behind  this 
mental  disorder  in  inmates. 

♦  *  *  correctional  institutions  throughout  the  country  have  been  plagued  with 
serious  problems.  These  have  included  work  strikes,  violent  incidents  and  racial 
tensions.  In  the  Federal  System,  we  have  experienced  a  number  of  difficulties, 
but  fortunately  none  have  involved  violence.  These  recent  incidents  have  high- 
lighted the  root  causes  of  the  problems  in  our  present  correctional  systems : 
overcrowded,  archaic  institutions,  inadequate  treatment  programs,  and,  in  some 
instances,  policies  and  procedures  which  serve  to  dehumanize  individuals  in 
confinement. 

The  Bureau  of  Prisons  cites  overcrowding  as  the  major  contributing 
cause  of  the  dehumanization  and  violence  of  federal  inmates.  The  Bu- 


93-999  O  -  73  -  pt.  3  —  16 


1030 

reau,  therefore,  creates  behavior  modification  programs  to  institu- 
tionalize the  inmate  and  make  him  amenable  to  the  basic  problem  of 
overcrowding. 

The  Federal  Bureau  of  Prisons  has  an  active  program  of  behavior 
therapy.  In  the  Springfield,  Missouri  Medical  Facility,  Project 
START  attempts  "to  develop  behavioral  and  attitudinal  changes  in 
offenders  who  have  not  adjusted  satisfactorily  to  institutional  settings." 
One  criterion  for  transfer  to  this  project  is  that  the  inmate  should  be 
"from  the  sending  institution's  segregation  unit."  There  are  no  volun- 
teers, only  involuntary  transfers.  {Operations  Memorandum^  7300.128, 
Bureau  of  Prisons,  October  25,  1972.)  Group  therapy  and  other  psy- 
chological techniques  have  been  employed  in  Marion,  Illinois,  and  in 
Terre  Haute,  Indiana,  as  well  as  elsewhere  in  the  federal  system. 

An  example,  which  raises  the  constitutional  questions  surrounding 
behavioral  modification  in  the  prison  setting,  comes  from  my  own  state. 
As  part  of  the  Bureau  of  Prisons'  ten-year  construction  plan,  a  Beha- 
vioral Research  Center  is  nearing  completion  at  Butner,  North  Caro- 
lina. The  facility,  for  which  plans  have  been  in  the  making  for  several 
years,  will  house  a  treatment  center  for  mentally  disturbed  inmates 
and  a  research  facility  to  develop  correctional  programs  for  export  to 
federal  and  state  institutions.  To  gain  more  information  about  the 
Butner  facility,  the  Subcommittee  on  Constitutional  Rights  contracted 
Director  Norman  Carlson  of  the  Bureau  of  Prisons.  In  response,  the 
Director  stated  that  safeguards  will  exist  at  Butner  to  protect  inmates 
and  that  all  programs  will  conform  to  established  guidelines  for  pro- 
grams involving  human  subjects.  The  guidelines  employed,  the  Direc- 
tor explained,  were  the  Nuremberg  standards  and  a  directive  by  the 
Public  Health  Service  on  experiments  involving  human  subjects.  Both 
documents,  it  should  be  noted,  require  that  an  individual  be  free  from 
coercion  in  making  his  decision  to  participate  in  a  project  and  so  situ- 
ated that  he  is  free  to  refuse.  The  Bureau  hopes  that  prisoners  will 
volunteer  to  go  to  Butner.  However,  in  order  to  secure  certain  types 
of  inmates  for  the  research  section,  involuntary  transfers  may  be  re- 
quired. Director  Carlson  also  assured  the  Subcommittee  that  no  psy- 
chosurgery or  massive  drug  doses  will  be  employed. 

The  Director's  reply  leaves  a  number  of  problems  unresolved. 

Behavior  modification  creates  problems  for  privacy  and  individual 
dignity  when  administered  in  a  custodial  setting  where  coercion  is  a 
practical  fact.  True  voluntary  participation  is  difficult  if  not  impos- 
sible in  a  prison.  The  Supreme  Court  in  Stanley  v.  Georgia^  894  U.S. 
557  (1968)  stated  the  problems  that  governmental  invasions  of  privacy 
pose  for  the  First  Amendment. 

Our  whole  constitutional  heritage  rebels  at  the  thought  of  giving  government 
the  power  to  control  men's  minds.  .  .  .  Whatever  the  power  of  the  state  to  control 
public  dissemination  of  ideas  inimical  to  the  public  morality,  it  cannot  consti- 
tutionally premise  legislation  on  the  desirability  of  controlMng  a  person's  private 
thoughts. 

This  same  right  of  privacy  of  the  individual  from  governmental 
invasion  was  strongly  stated  in  Grisirold  v.  Connecticut^  381  U.S.  479 
(1965),  which  was  based  as  well  on  the  Fourth.  Fifth  and  Ninth 
Amendments. 

A  prisoner's  rights  are  not  infrin.<red  by  his  involuntary  transfer 
to  a  higher  security  grade  or  to  a  medical  facility  because  he  is  overtly 
psychotic.  But  when  he  is  forced  to  participate  in  a  treatment  or  ex- 


1031 

periment  which  is  not  to  treat  a  present  illness,  but  rather  to  fit  a  goal 
set  by  the  Bureau  for  rehabilitation,  and  which  involves  drugs  or 
coercive  measures  to  change  his  very  personality,  due  process  and 
equal  protection  requirements  come  into  play.  One  must  ask,  should 
a  prisoner  who  is  not  judged  mentally  ill  by  the  court  after  psychiatric 
tests  be  judged  so  by  the  Bureau  of  Prisons  after  incarceration  and 
then  forced  to  accept  treatment?  Indeed,  in  any  place  where  consent 
is  coerced  or  not  given  freely,  there  seems  to  be  a  violation  of  a  basic 
human  right,  be  it  in  a  prison  or  conceivably  even  in  a  private  doctor's 
office.  If  treatment  is  forced  without  a  hearing  or  inquiry  and  without 
true  consent,  is  not  the  due  process  assured  every  citizen — inmate  or 
free — denied? 
The  programs  exemplified  by  Butner  raise  some  very  serious  issues : 

1.  How  does  a  rehabilitation  program  which  involves  behavior 
therapy,  be  it  transactional  analysis  (game  theory)  or  operant  condi- 
tioning (reward/punishment  theory),  fit  the  Bureau's  statutory  au- 
thorization under  Title  18  of  the  United  States  Code  ? 

2.  The  Constitution  secures  privacy  and  due  process  for  all  Amer- 
icans. Are  these  rights  violated  when  an  inmate  is  forced  to  undergo  a 
psychological  therapy  because  his  consent  occurred  in  a  coercive  set- 
ting ?  Can  an  inmate  freely  volunteer  for  a  program  to  alter  his  mind 
when  he  is  in  a  prison  setting?  Testimony  before  the  Health  Sub- 
committee indicates  that  prisoners  took  part  in  programs  in  a  prison 
that  they  would  never  consent  to  in  a  free  world  setting. 

3.  The  records  of  a  stay  at  Butner  and  any  treatment  will  be  in- 
tegrated with  an  inmate's  files.  Is  his  privacy  assured  where  such 
records  can  be  disseminated  to  the  parole  board  or  beyond  the  con- 
fines of  the  Bureau  of  Prisons?  The  problem  here  is  similar  to  that 
uncovered  by  the  Subcommittee  on  Constitutional  Eights  in  its  con- 
tinuing investigation  of  data  banks  and  the  dissemination  of  arrest 
records  and  other  highly  personal  information. 

4.  The  Eighth  Amendment  protection  against  cruel  and  unusual 
punishment  may  be  violated  where  an  inmate  is  involuntarily  sent  to 
a  therapy  program.  Does  this  not  constitute  a  sentencing  beyond  that 
of  a  judge?  Does  it  not  amount  to  an  extra  punishment?  Therapy  pro- 
grams which  employ  aversive  therapy — inflicting  pain  to  dissuade 
certain  behavior  by  the  use  of  drugs  or  prolonged  isolation — as  part 
of  their  treatment  could  well  be  violations  of  the  Eighth  Amendment. 

My  concern  with  Butner  is  not  that  its  program  development  con- 
cept will  develop  new  programs  for  managing  prisons,  but  rather  that 
the  development  will  be  costly  to  the  rights  of  inmates  and  that  the 
developed  programs  may  not  resolve  the  prison  system's  dehuman- 
izing effect.  My  concern  with  the  psychiatric  treatment  center  at  But- 
ner is  not  that  psychotic  patients  will  be  removed  from  the  general 
prison  population,  but  that  there  are  problems  of  identification  of  in- 
mates for  treatment :  that  inmates  will  undergo  treatment  in  a  coercive 
atmosphere,  signing  a  consent  form  they  may  never  understand  or 
because  they  want  to  appear  cooperative  to  the  parole  board ;  and  that 
there  are  possibilities  of  abuse  in  transfers  to  the  unit.  Congress  has  a 
duty  to  maintain  some  form  of  oversight  over  prison  research  and 
treatment  to  assure  that  constitutional  liberties  are  not  lost  under  the 
rationale  of  prison  experimentation  and  prison  management. 


1032 

Equally  voiceless  in  our  society,  because  of  segregation  from  the 
general  population,  are  patients  in  mental  institutions  and  Veterans 
Administration  hospitals.  Here  the  problems  are  somewhat  different 
than  in  a  prison  setting.  Often  the  problem  for  a  mental  patient  is  to 
secure  treatment  and  not  just  be  maintained  in  a  custodial  setting. 
Behavior  modification  is  a  part  of  treatment.  In  hearings  before  the 
Subcommittee  on  Constitutional  Rights  in  1970  on  the  rights  of  the 
mentally  ill,  it  was  pointed  out  that  90  percent  of  all  mental  hospital 
inmates  were  there  by  judicial  commitment.  Certainly  when  the  court 
places  a  person  in  a  confined  hospital  setting,  as  in  a  prison,  there  must 
be  maintenance  of  constitutionally  guaranteed  liberties.  The  problems 
of  behavior  modification  in  a  mental  hospital  are  not  the  correctness 
or  appropriateness  of  treatment  but  rather  problems  related  to  the 
protection  of  the  rights  of  an  individual  undergoing  treatment.  The 
recent  abuses  exposed  in  the  Willowbrook  hospital  and  in  mental  hos- 
pitals in  Alabama  point  to  the  need  for  improved  oversight  of  feder- 
ally funded  private  and  public  mental  hospitals  to  insure  that  pa- 
tients are  given  the  basic  courtesies  and  dignities  afforded  other  citizens. 

The  extent  to  which  mental  patients  or  veterans  are  used  for  ex- 
perimentation and  development  of  new  methods  of  therapies  has  not 
been  investigated.  It  is  appropriate  that  such  an  investigation  occur 
and  that  the  Congress  consider  some  form  of  permanent  review  of  a 
problem  which  affects  the  lives  of  nearly  a  million  Americans  daily 
and  a  larger  number  of  our  citizens  indirectly.  The  constitutional  prob- 
lems for  the  veteran  or  mentally  disturbed  person  are  similar  to  those 
of  the  prisoner — coercion  for  treatment  and  experiment,  lack  of  in- 
formed consent,  where  possible,  and  lack  of  control  over  custodial  care 
and  medical  practices.  The  involuntary  nature  of  judicial  commitment 
and  the  subjection  to  imposed  treatments  demands  the  congressional 
concern  for  the  patient  who  cannot  speak  for  himself.  I  will  not  go 
into  detail  about  the  rights  of  the  mentally  ill ;  the  hearings  speak  for 
themselves.  I  want  only  to  express  my  concern  at  this  point  for  the 
possible  abuses  in  hospitals  and  the  need  to  ensure  that  basic  constitu- 
tional guarantees  are  not  denied  without  due  process  of  law. 

I  would  like  to  reiterate  that  I  fully  understand  the  difficulties  in- 
herent in  intervention  into  the  realm  of  scientific  experiment.  I  com- 
mend you  on  your  willingness  to  venture  into  this  area.  Some  of  the 
shocking  abuses  you  have  exposed  as  in  the  Alabama  syphillis  study 
and  the  unapproved  uses  of  approved  drugs  need  to  be  brought  to  the 
attention  of  the  Congress.  The  constitutional  problems  are  of  great 
consequence.  Any  citizen  may  seek  mental  care  assistance  at  some 
point  in  his  life  and  suddenly  find  himself  to  be  a  subject  for  a  doctor 
conducting  an  experiment.  To  assure  that  all  constitutional  protections 
are  afforded  in  medical  experimentation  and  treatment  programs  is 
a  goal  of  the  utmost  importance.  Whether  that  assurance  is  in  the 
form  of  congressional  control,  professional  self-restraint  or  state  in- 
tervention is  secondary  to  the  basic  humanitarian  and  social  considera- 
tions. 

Senator  Kennedy,  We  will  begin  today  by  receiving  testimony 
from  two  of  the  participants  in  the  Tuskagee  Study.  Last  October, 
an  ad  hoc  advisory  group  to  HEW  recommended  immediate  medical 
care  be  given  the  participants.  Assistant  Secretary  DuVal  pledged 


1033 

prompt  action.  Last  week  the  ad  hoc  group  complained  that  no  action 
had  been  taken. 

This  was  followed  by  another  pledge,  this  time  from  Secretary 
Weinberger.  We  have  invited  these  study  participants  today  to  real- 
firm  our  commitment  to  them  to  be  sure  that  they  get  a  full  public 
hearing  on  their  grievances  and  to  pledge  that  we  will  follow  the  way 
HEW  implemented  the  ad  hoc  committee  recommendations.  If 
needed,  we  will  consider  legislation  to  remedy  this  tragic  situation. 

Our  first  witness  is  Mr.  Fred  Gray,  of  the  State  of  Alabama.  Then 
we  will  introduce  Mr.  Lester  Scott  and  Mr.  Charley  Pollard,  with  per- 
sonal experience  as  participants. 

STATEMENT  OF  FRED  GRAY,  ATTORNEY  AND  LEGISLATOR,  STATE 
OF  ALABAMA,  ACCOMPANIED  BY  LESTER  SCOTT  AND  CHARLES 
POLLARD 

Mr.  Gray.  Mr.  Chairman  and  members  of  the  committee,  as  has 
been  indicated  I  am  Fred  Gray,  a  member  of  the  Alabama  Legis- 
lature, representing  Barbour,  Bullock,  and  Macon  Counties.  Tuske- 
gee  is  the  county  seat  of  Macon  County.  I  am  also  an  attorney 
and  as  such  I  represent  about  40  of  the  living  participants  in  the  Tus- 
kegee  Study.  It  is  in  that  capacity  that  I  appear  before  this  committee 
today. 

We  also  represent  heirs  of  approximately  15  families  of  the  deceased 
participants.  By  letter  dated  January  23rd,  one  of  the  participants, 
Mr.  Pollard,  who  is  here  today,  was  invited  by  the  Chairman  of  the 
Tuskegee  Syphilis  Study  Ad  Hoc  Advisory  Panel  to  come  to  Wash- 
in^on  for  an  interview  before  that  panel. 

On  January  30th,  by  letter,  as  counsel  for  Mr.  Pollard,  I  accepted 
that  invitation.  However,  I  received  no  reply  to  my  letter.  Siibse- 
quently,  I  read  in  the  press  that  the  Ad  Hoc  Panel  was  having  a  pub- 
lic meeting  here  in  Washington  on  February  23rd. 

I  sent  a  night  letter  to  the  panel  stating  that  I  represented  some  of 
the  participants  in  the  Tuskegee  Study,  and  requested  an  opportunity 
to  present  their  views  to  the  panel.  This  request  was  denied.  Never- 
theless, I  came  to  Washington  and  attended  that  hearing,  but  was  de- 
nied the  right  to  present  the  views  of  the  participants  even  though  the 
panel  received  evidence  from  persons  who  had  conducted  the  study. 

Therefore,  on  behalf  of  these  participants,  I  would  like  to  thank 
Senator  Kennedy,  Chairman  of  this  Subcommittee,  for  the  oppor- 
tunity to  present  the  views  of  the  participants  in  the  Tuskegee  Study. 

This  is  the  first  time  that  any  governmental  agency  has  permitted 
them  to  present  their  side  of  the  story.  I  have  brought  with  me  twa 
of  the  pa>rticipants,  Mr.  Pollard  and  Mr.  Scott. 

According  to  the  participants,  this  is  how  they  became  involved  in 
the  Tuskegee  Study.  In  1932,  notices  were  issued  by  Dr.  Smith  and 
Nurse  Rivers,  announcing  a  new  health  program  in  Macon  County. 

These  notices  were  circulated  throughout  the  county  by  mail  and  at 
churches  and  schools.  The  new  program  consisted  of  taking  blood  tests. 
Only  blacks  were  given  notices  and  only  black  males  subsequently  par- 
ticipated in  the  program.  They  were  uneducated,  poor,  and  lived  in 
rural  areas.  No  whites  were  selected  to  participate  in  the  study. 

After  the  blood  tests  were  taken,  the  men  were  told  various  things 


1034 

by  those  in  charge.  Some  were  told  they  had  bad  blood.  However,  they 
did  not  know  what  bad  blood  meant  at  that  time. 

Others  were  told  nothing  of  what  they  had.  None  Avere  ever  told  they 
had  syphilis.  Most  knew  nothing  about  syphilis.  They  were  not  told 
they  were  involved  in  a  study.  I 

The  participants  never  signed  any  written  consent  nor  were  they 
asked  to  sign  one.  Some  were  told  they  would  receive  money  but  some 
never  did.  Many,  however,  received  $25  and  a  25-year  certificate  of 
appreciation  in  1958. 

I  have  brought  with  me  a  typical  copy  of  that  certificate.  Some  fami- 
lies received  money  for  burial  expenses  if  they  permitted  autopsies. 
This  amount  ranged  from  $25  to  $75  to  $100  depending  upon  when  the 
participant  died. 

Some  participants  were  also  promised  free  hot  lunches,  free  trans- 
portation to  be  examined.  The  method  used  to  persuade  the  partici- 
pants in  the  study  are  best  described  in  an  article  written  by  Nurse 
Kivers  and  two  of  the  physicians  of  the  Public  Health  Service.  This 
is  what  they  said  as  to  how  they  induced  these  blacks  to  become 
involved. 

"Because  of  the  lower  educational  status  of  a  majority  of  the  pa- 
tients, such  as  farmers  and  day  laborei-s,  it  was  impossible  to  appeal 
to  them  from  a  purely  scientific  approach.  Therefore,  various  methods 
were  used  to  maintain  and  stimulate  their  interest :  free  medicine,  ex- 
cept penicillin;  burial  assistance  or  insurance,  the  project  being  re- 
ferred to  as  'Miss  Rivers'  Ix)d2re';  free  ^^ot  meals  on  tl^e  day  of  the 
examination  by  Public  Health  Service  physicians  periodically,  trans- 
portation to  and  from  the  hospital  and  an  opportunity  to  stop  in  town 
on  the  return  trip  to  shop  or  visit  with  friends." 

All  participants  were  administered  shots.  Virtually  none  of  those 
interviewed  knew  the  purpose  of  the  shots,  but  assumed  they  were  for 
bad  blood.  One  participant  said  the  shots  were  called  606  shots.  Most 
believed  the  treatment  was  adequate  for  their  medical  problems. 

Many  participants  received  a  spinal  injection  early  in  the  program. 
All  shots  were  given  during  the  early  1930's. 

Many  of  them  have  forgotten  the  frequency  of  the  examinations  but 
thought  that  they  were  examined  about  once  a  year  from  the  incep- 
tion of  the  program  until  about  1952  and  then  every  two  years. 

The  examinations  included  X-rays  on  at  least  two  occasions.  They 
were  made  at  various  places,  including  local  churches,  local  schools, 
the  Veterans  Administration  Hospital  and  John  Andrews  Hospital  in 
the  Macon  County  Health  Center. 

All  participants  were  given  a  green  colored  tonic  and  white  pills. 
Sometime  in  the  late  40's  or  early  50's.  there  was  a  massive  effort  to 
get  all  persons  in  Macon  County  treated  who  had  syphilis.  Most  of  the 
whites  and  many  blacks  were  sent  to  Birmingham  to  receive  such 
treatment. 

However,  those  who  participated  in  tlie  Tuskegee  Study  were  not 
permitted  to  receive  such  treatment.  It  was  not  until  the  summer  of 
1972  that  the  participants  learned  through  the  news  media  that  they 
were  part  of  the  Tuskegee  Study  and  many  of  those  persons  even 
today  still  do  not  know  that  they  have  syphilis  or  that  they  are  part  of 
a  study. 


1035 

The  participants  in  this  study  are  firmly  convinced  that  the  United 
States  Government  in  the  manner  in  which  this  study  was  conducted 
violated  their  Constitutional  rights. 

They  feel  that  the  Government  knew  they  had  syphilis  and  failed  to 
treat  them. 

Second,  they  feel  that  Public  Health  Service  failed  to  fully  disclose 
to  them  that  they  had  syphilis,  that  they  were  participating  in  a  study, 
and  that  treatment  was  available  for  syphilis. 

They  further  feel  that  Public  Health  Service  led  many  participants 
to  believe  that  they  were  being  properly  treated  for  whatever  diseases 
they  had  when  in  fact  they  were  not  being  treated  at  all. 

Public  Health  Service  failed  to  obtain  the  participants'  written 
consents  to  be  a  part  of  the  study. 

Last,  but  we  think  very  importantly,  the  study  was  racially  moti- 
vated and  it  discriminated  against  blacks  in  that  no  whites  were 
selected  to  participate  in  the  study  and  only  those  recruited  were  poor, 
uneducated,  rural  blacks. 

For  40  years  the  life  and  death  of  these  participants  have  been 
determined  by  white  Americans  who  had  little  or  no  concern  for  the 
well  being  of  black,  uneducated,  rural  Alabamans  during  depression 
days.  Others  directed  their  lives  as  to  whether  they  would  live  or 
die  or  be  treated  or  not  treated,  whether  they  would  live  long  or  die 
young. 

From  all  indications,  the  current  agency  which  has  expressed  some 
concern  about  the  participants  in  the  Tuskegee  Study  have  continued 
this  same  course  of  action  and  now  making  recommendations  to  the 
Government  that  they  should  be  given  some  type  of  medical  treatment. 

We  firmly  believe,  and  these  participants  believe,  that  they  should 
have  a  right  tx)  determine  and  should  have  some  input  in  telling  the 
Government  what  they  are  entitled  to  as  a  result  of  having  been  used 
as  human  guinea  pigs  for  40  years. 

The  participants  want  the  right  to  tell  the  Government  what  they 
want.  What  do  they  want?  First  of  all,  they  do  not  want  Public 
Health  Service  at  this  late  date  to  give  them  medical  treatment.  It  is 
this  agency  which  has  failed  and  refused  to  treat  them  during  this 
period  of  time. 

They  have  no  faith,  trust,  nor  confidence  that  the  Public  Health 
Service  will  properly  examine  them  and  give  them  proper  treatment. 
Any  medical  statement  or  any  medical  treatment  coming  from  Public 
Health  Service  in  the  opinion  of  the  participants  would  be  to  cover 
up  their  unlawful  conduct  during  the  past  40  years. 

What  these  participants  want  is  adequate  compensation  to  compen- 
sate them  for  being  used  by  the  Government  as  guinea  pigs  for  more 
than  40  years,  the  most  productive  period  of  their  lives.  With  adeouate 
compensation  for  the  first  time  since  they  were  youngsters,  they  will  be 
able  to  determine  the  course  of  tl^eii*  lives  during  their  twilight  years 
without  governmental  interference. 

With  this  compensation,  they  can  select  their  own  physicians,  hos- 
pitals and  medical  technicians  who  will  give  them  medical  attention. 

On  behalf  of  these  participants,  we  urge  this  subcommittee  to  care- 
fully review  their  plight  and  take  appropriate  legislative  action  to 
correct  the  wrongs  which  they  have  suffered,  and  enact  proper  safe- 
guards to  see  that  such  a  study  never  occurs  again  in  this  country. 


1036 

Mr.  Chairman,  Mr.  Pollard  is  to  my  left,  Mr.  Scott  is  to  my  right, 
and  they  are  available  for  any  questions. 

Senator  Kennedy.  Thank  you  very  much,  Mr.  Gray. 

Will  you  tell  me  whether  there  were  participants  in  this  study  that 
actually  died  ? 

Mr.  Gray.  It  is  my  understanding,  Mr.  Chairman,  from  several  of 
the  published  reports  that  something  in  excess,  I  believe,  of  20  persons 
died  and  they  attributed  the  cause  to  syphilis. 

Senator  Kennedy.  Are  all  the  participants  in  the  study  aware  at 
the  present  time  that  they  were  involved  in  a  study? 

Mr.  Gray.  They  were  never  aware  of  that  fact  until  last  summer. 

Senator  Kennedy.  They  have  all  been  notified  now  ? 

Mr.  Gray.  Not  all,  because,  you  see,  some  of  these  people  are  not  in 
the  area.  Some  still  don't  know.  As  a  matter  of  fact,  during  the  last 
two  weeks,  we  had  four  or  five  persons  who  dropped  by  our  office  and 
who  told  us  they  were  involved  in  the  study  and  wanted  us  to  do  some- 
thing for  them. 

Senator  Kennedy.  Maybe  we  could  talk  a  little  bit  with  Mr.  Scott 
and  Mr.  Pollard. 

Maybe  both  of  you  gentlemen  would  be  kind  enough  to  tell  us  a  little 
bit  how  you  were  first  enrolled  in  the  study,  how  you  heard  about  it, 
if  you  can  remember  back  to  those  days,  how  you  became  enrolled. 

Let's  start  with  you,  Mr.  Pollard.  Would  you  tell  us  a  little  bit  about 
how  you  heard  about  this  study,  how  you  became  involved  ? 

Mr.  Pollard.  Back  in  1932, 1  was  going  to  school  back  then  and  they 
came  around  and  said  they  wanted  to  have  a  clinic  blood  testing  up 
there. 

Senator  Kennedy.  How  old  were  you  then  ? 

Mr.  Pollard.  How  old  was  I  ?  Well,  I  was  bom  in  1906.  I  had  been 
married — no,  I  hadn't  been  married.  Anyhow,  they  came  around  and 
give  us  the  blood  tests.  After  they  give  us  the  blood  tests,  all  up  there 
in  the  community,  they  said  we  had  bad  blood.  After  then  they  started 
giving  us  the  shots  and  give  us  the  shots  for  a  good  long  time.  I  don't 
remember  how  long  it  w^as.  But  after  they  got  through  giving  us  those 
shots,  they  give  me  a  spinal  tap.  That  was  along  in  1933.  They  taken 
me  over  to  John  Henry  Hospital. 

Senator  Kennedy.  That  is  rather  unpleasant,  isn't  it,  a  spinal  tap  ? 

Mr.  Pollard.  It  was  pretty  bad  with  me. 

Senator  Kennedy.  I  have  had  a  spinal  tap  myself.  They  stick  that 
big,  long  needle  into  your  spine. 

Mr.  Pollard.  That  is  right,  at  John  Andrew  Hospital.  After  that, 
we  went  over  early  that  morning,  a  couple  of  loads  of  us,  and  they 
taken  us  upstairs  after  giving  us  the  spinal  shot.  They  sit  me  down  in 
the  chair  and  the  nurse  and  the  doctor  got  behind  and  give  me  the  shot. 
Then  they  take  us  upstairs  in  the  elevators,  our  heels  up  and  head 
doWn.  They  kept  us  there  until  five  o'clock  that  evening,  and  then  the 
nurse  brought  us  back  home. 

After  then,  I  stayed  in  the  bed.  I  had  taken  down  a  day  or  two  after 
I  got  through  with  the  spinal  tap.  I  stayed  in  bed  10  days  or  two  weeks 
and  the  nurse  came  out  there  and  give  me  pome  pills.  I  don't  think  she 
give  me  any  of  the  medicine  at  that  time,  but  just  gave  me  some  of  the 
pills.  Anyhow,  she  made  several  trips  out  there  and  I  finally  got  in 
pretty  good  shape  afterwards.  It  looked  like  my  head  was  going  back. 


1037 

So  after  then  they  went  to  seen  us  once  a  year.  They  sent  out  notices 
for  us  to  meet  at  Shiloh  School.  Sometimes  they  would  just  take  the 
blood  sample  and  give  us  some  medicine  right  there  at  the  school,  under 
the  oak  tree  where  we  met  at  Shiloh. 

Senator  Kennedy.  This  is  a  small  community  ? 

Mr.  Pollard.  It  is  a  small  community. 

Senator  Kennedy.  How  many  people  are  in  the  community  ? 

Mr.  Pollard.  Well,  Tuskegee  is  about  12,000,  but  this  other  little 
place  up  there  I  imagine  is  a  couple  thousand  people  there.  I  am  about 
three  and  a  half  miles  out. 

Senator  Kennedy.  What  would  you  do,  come  into  town  ? 

Mr.  Pollard.  That  is  right,  go  into  town. 

Senator  Kennedy.  Did  they  have  a  little  clinic  there  or  a  little 
hospital  ? 

Mr.  Pollard.  They  didn't  have  any  of  that. 

Senator  Kennedy.  What  did  you  do,  just  meet  under  the  tree? 

Mr.  Pollard.  Yes,  at  Shiloh  School.  It  was  about  two  and  a  half 
miles  out.  It  is  10  miles  between  there  and  Tuskegee. 

Senator  Kennedy.  What  did  they  do,  ask  you  to  come  back  once  in  a 
while  or  every  couple  of  weeks  ? 

Mr.  Pollard.  Tnat  is  it.  They  would  give  us  the  date  to  come  back 
and  take  those  shots. 

Senator  Kennedy.  What  were  the  shots  for,  to  cure  the  bad  blood  ? 

Mr.  Pollard.  Bad  blood,  as  far  as  I  know  of. 

Senator  Kennedy.  Did  you  think  they  were  curing  bad  blood  ? 

Mr.  Pollard.  I  didn't  know.  I  just  attended  the  clinic. 

Senator  Kennedy.  They  told  you  to  keep  coming  back  and  you  did  ? 

Mr.  Pollard.  When  they  got  through  giving  the  shots,  yes.  Then 
they  give  us  that  spinal  puncture. 

Senator  Kennedy.  Did  they  tell  you  why  they  were  giving  a  spinal 
puncture  ? 

Mr.  Pollard.  No. 

Senator  Kennedy.  Did  you  think  it  was  because  they  were  trying  to 
help  you  ? 

Mr.  Pollard.  To  help  me,  yes. 

Senator  Kennedy.  You  wanted  some  help  ? 

Mr.  Pollard.  That  is  right.  They  said  I  had  bad  blood  and  they  was 
working  on  it. 

Senator  Kennedy.  How  long  did  they  keep  working  on  it? 

Mr.  Pollard.  After  that  shot,  that  spinal  shot 

Senator  Kennedy.  When  was  that  ? 

Mr.  Pollard.  That  was  in  1933. 

Senator  Kennedy.  1933  ? 

Mr.  Pollard.  That  is  right.  I  don't  remember  what  month  it  was  in, 
but  I  know  it  was  in  1933. 

Senator  Kennedy.  Did  they  treat  you  after  that  ?  Did  they  treat  you 
after  1933? 

Mr.  Pollard.  Yes.  They  treat  me  every  year.  They  would  come 
down  and  see  us  every  year.  Of  course,  during  that  time,  after  I  taken 
that  spinal  puncture,  I  wore  a  rubber  belt  around  my  stomach.  It  had 
a  long  strand  around  it  and  I  would  run  it  around,  come  back  in  front 
and  tie  it  in  a  bow  knot.  They  used  a  little  ointment  or  salve  that  I 
rubbed  on  my  stomach.  I  reckon  I  w^ore  it  a  year  or  six  months,  some- 


1038 

thing  like  that.  After  then  they  would  see  us  once  a  year  up  to  25  years. 

Senator  Kennedy.  During  this  time,  did  they  indicate  to  you  what 
kind  of  treatment  they  were  giving  you,  or  that  you  were  involved 
in  any  kind  of  test  or  experiment  ? 

Mr.  Pollard.  No,  they  never  did  say  what  it  was. 

Senator  Kennedy.  What  did  you  think  they  were  doing,  just  trying 
to  cure  the  bad  blood  ? 

Mr.  Pollard.  That  is  all  I  knew  of. 

Senator  Kennedy.  Did  they  ever  take  any  more  blood  and  examine 
it  and  tell  you  the  blood  was  getting  better  ? 

Mr.  Pollard.  They  would  take  out  blood,  though. 

Senator  Kennedy.  What  did  they  tell  vou  after  they  would  take  the 
blood? 

Mr.  Pollard.  They  would  just  give  us  the  pills  and  sometimes  they 
would  give  us  a  little  tablet  to  put  undei*  our  tongue  for  sore  throats. 
Then  they  would  give  us  the  green  medicine  for  a  tonic  to  take  after 
meals. 

Senator  Kennedy.  You  thought  they  were  ti*eating  the  bad  blood  ? 

Mr.  Pollard.  That  is  right. 

Senator  Kennedy.  During  this  time  did  they  ever  give  you  any  com- 
pensation or  any  money  ? 

Mr.  Pollard.  After  that  25  years  thev  gave  me  $25,  a  $20  and  a 
$5  bill. 

Senator  Kennedy.  After  25  years  ? 

Mr.  Pollard.  That  is  it.  They  give  me  a  certificate. 

Senator  Kennedy.  They  gave  you  a  what  ? 

Mr.  Pollard.  They  gave  me  a  certificate  and  a  picture  with  six  of  us 
on  there. 

Senator  Kennedy.  What  did  the  certificate  say,  do  you  remember  ? 

Mr.  Pollard.  This  is  one  of  them  here  in  my  hand. 

Senator  Kennedy.  It  is  a  certificate  of  merit,  is  it  ? 

"U.S.  Public  Health  Service.  This  certificate  is  awarded  in  grate- 
ful recognition  of  25  years  of  participation  in  the  Tuskegee  Medical 
Research  Study." 

Mr.  Pollard.  I  have  one  of  these  and  then  I  liave  one  with  a  picture 
of  five  more  on  it. 

Senator  Kennedy.  Were  you  glad  to  get  it  ?  Were  you  glad  to  get 
that  certificate  ? 

Mr.  Pollard.  Yes. 

Senator  Kennedy.  You  were  glad  to  get  the  $25. 

Mr.  Pollard.  That  is  right.  I  used  the  $25. 

Senator  Kennedy.  Did  they  ever  offer  you  anything  else  ?  Did  they 
ever  offer  you  any  kind  of  free  meals  or  free  rides,  anything  like  that? 

Mr.  Pollard.  No.  We  would  have  a  lunch  when  we  would  go  over  to 
the  Veterans  Hospital.  We  would  go  to  the  canteen  and  have  lunch.  A 
lot  of  times  I  went  in  my  own  car  and  I  would  help  the  nurse  carry 
the  boys  down  there  sometimes,  a  lot  of  times.  I  would  always  go  in  my 
car  a  lot  of  times. 

Senator  Kennedy.  Sometime  last  fall  did  you  hear  or  read  about 
the  experiment  that  was  taking  place,  the  study  that  was  taking  place 
on  you  and  some  of  the  others  that  were  supposed  to  have  bad  blood  ? 

Mr.  Pollard.  Back  last  year? 

Senator  Kennedy.  Yes. 


1039 

Mr.  Pollard.  Yes. 

Senator  Kennedy.  Would  you  tell  us  a  little  bit  about  that,  how  you 
first  heard  about  it,  and  what  your  reaction  was  to  it  ? 

Mr.  Pollard.  The  people  that  contacted  me  at  the  stockyard 

Senator  Kennedy.  Is  that  where  vou  worked  ? 

Mr.  Pollard.  That  is  where  I  worked  when  they  contacted  me.  A 
heavy  built  lady  contacted  me. 

Senator  Kennedy.  How  long  have  you  worked  at  the  stockyard  ? 

Mr.  Pollard.  I  wasn't  working  out  there.  I  was  taking  some  cows 
down  there  last  summer,  my  grandboy  and  myself. 

Senator  Kennedy.  How  old  is  he  ? 

Mr.  Pollard.  The  grandboy  ? 

Senator  Kennedy.  Yes. 

Mr.  Pollard.  He  is  17. 

Senator  Kennedy.  So  you  were  taking  some  cows  down  to  the 
stockyard  ? 

Mr.  Pollard.  That  is  it.  I  was  taking  the  cows  down  there.  A  lady 
came  up  to  me  and  asked  about  Charles  Pollard.  I  looked  at  my  grana- 
boy  ana  said,  "I  didn't  know  Charles  Pollard.  I  knew  Charles  Wesley 
Pollard,''  and  she  said,  "Yes,  you  are  the  one."  She  said  she  had  been 
all  over  and  asked  about  me  but  nobody  had  seen  me.  But  I  had  been 
on  the  payroll  bringing  cows  down  there. 

Afterwards,  she  told  me  to  go  ahead  and  get  my  cows  unloaded 
and  to  come  back  out  there,  that  she  wanted  to  talk  with  me.  So  that 
is  what  I  did. 

Senator  Kennedy.  So  you  went  out  and  talked  to  her  ? 

Mr.  Pollard.  That  is  right. 

Senator  Kennedy.  What  did  she  tell  you  ? 

Mr.  Pollard.  She  asked  me  wasn't  I  in  a  study  or  a  clinic  back 
40  years  ago.  I  looked  at  my  grandboy  then  and  he  looked  back.  I 
had  done  forgot  about  it.  I  said,  "Yes,  I  was  in  a  clinic  back  in  that 
time  but  I  have  done  forgot  about  it."  So  she  wanted  to  know  the 
story  of  it. 

You  see,  after  them  25  years,  the  doctors  started  them  two  years 
and  after  that  went  for  about  three  years.  I  haven't  seen  them  in  the 
last  three  or  four  years. 

Senator  Kennedy.  You  haven't  seen  them  in  the  last  three  or  four 
years  ? 

Mr.  Pollard.  No.  I  told  her  the  best  I  could  about  it,  what  I  could 
remember. 

Senator  Kennedy.  Were  you  surprised  when  you  heard  about  it? 

Mr.  Pollard.  That  is  right,  I  was  surprised. 

Senator  Kennedy.  Were  you  a  little  mad  that  you  were  sort  of 
being  used  in  a  test  that  you  didn't  know  about  ? 

Mr.  Pollard.  Well,  at  that  time,  you  see,  I  didn't  know  nothing 
about  it  until  well  after  I  got  back  home.  I  had  taken  the  Birminsfham 
News.  I  have  been  taking  it  for  25  or  30  years.  It  was  there.  What  I 
told  her  was  in  the  Birmingham  News  that  evening.  So  we  read  it, 
got  to  reading  it,  and  talking  about  black  men  in  Macon  County.  Of 
course,  the  week  before  then  they  had  told  in  the  news  there  about  400 
or  600  men,  whatever  it  was,  the  black  men  in  Macon  County,  but  I 
didn't  give  it  even  a  thought,  until  after  she  told  me  that.  That  was 
on  a  Tuesday  when  she  saw  me. 


1040 

Senator  Kennedy.  Have  you  seen  any  doctors  since  then  ?  Have  any 
doctors  come  down  to  see  you  and  help  you  at  all  recently  ? 

Mr.  Pollard.  Not  lately. 

Senator  Ej:nnedy.  In  the  last  few  months  ? 

Mr.  Pollard.  No.  The  Government  doctors,  no.  I  had  been  visiting 
a  doctor,  some  individual  doctors.  Of  course,  I  had  a  bad  case  of 
arthritis  last  year,  in  the  last  w^eek  in  January.  I  went  to  Montgomery 
to  a  doctor  for  a  month.  He  give  an  X-ray  on  me  and  sent  me  back  to 
the  bone  specialist  in  Tuskegee.  He  doctored  on  me  for  about  a  month 
and  I  got  on  crutches  and  stayed  on  them.  He  finally  told  me  to  go 
back  home.  If  it  never  did  get  no  worse,  don't  come  back.  So  I  am 
still  taking  medicine,  capsules  that  he  give  me.  That  was  after  he 
give  me  that  shot  in  the  hip. 

Senator  Kennedy.  Did  you  get  any  bill  from  the  doctor  for  seeing 
him  about  your  arthritis  ? 

Mr.  Pollard.  Did  I  get  a  bill  from  him  ? 

Senator  Kennedy.  Yes. 

Mr.  Pollard.  No,  because  I  paid  him  each  time. 

Senator  ICennedy.  You  paid  him  ? 

Mr.  Pollard.  Yes,  each  time.  That  was  my  doctor. 

Senator  Kennedy.  How  much  do  you  pay  for  a  visit  down  there? 

Mr.  Pollard.  The  X-ray  cost  me  $25  and  the  medicine  one  time 
cost  me  $15. 

Senator  Kennedy.  That  one  X-ray  was  equivalent  to  the  $25  you 
got  from  the  Government. 

Mr.  Pollard.  That  is  right.  And  after  then  I  went  back  and  got 
some  medicine.  I  think  I  had  to  pay  him  $10  that  trip.  He  didn't 
make  the  X-ray  until  to  wind  it  up.  Then  he  sent  me  back  to  Dr.  Hume, 
in  Tuskegee. 

Senator  Kennedy.  Did  you  pay  him,  too  ? 

Mr.  Pollard.  Dr.  Hume  ?  That  is  right. 

Senator  Kennedy.  Do  you  remember  how  much  that  was  ? 

Mr.  Pollard.  I  paid  him  $15,  I  think,  the  first  time.  On  the  next 
trip  I  think  I  paid  him  $10.  But  I  have  been  buying  the  medicine.  I 
bought  the  medicine  and  I  paid  for  the  medicine  at  the  desk. 

Senator  Kennedy.  It  runs  into  a  lot  of  money,  doesn't  it  ? 

Mr.  Pollard.  Yes,  when  you  go  to  these  hospitals.  Of  course,  back  in 
1961 1  had  an  operation.  I  had  a  gland  operation. 

Senator  Kennedy.  Mr.  Scott,  would  you  tell  us  a  little  bit  about 
how  you  heard  about  this  ? 

Mr.  Scott.  Yes.  In  1932,  we  were  all  on  the  farm  and  going  to 
school  and  Miss  Rivers  came  out  and  Dr.  Smith.  He  said  he  wanted 
to  see  all  of  us  people  around  there,  to  meet  at  the  school.  So  we  went 
out  and  he  said  the  purpose  was  to  take  the  test  of  blood.  So  he  drew 
blood  and  we  went  back  home. 

He  said  to  be  out  here  next  Wednesday.  We  went  back  and  he  said, 
"You  have  bad  blood  and  we  will  have  to  give  you  shots.-'  So  we 
would  go  up  every  week  or  sometimes  every  other  week,  and  take  shots. 
That  is  how  I  got  involved  in  that.  I  had  taken  the  shots  for  a  good 
long  while  and  then  left  the  county  to  go  to  another  community,  but 
we  would  meet  with  him. 

Senator  Kennedy.  How  long  did  you  take  the  shots  ? 

Mr.  Scott.  We  were  taking  those  shots  for  about  a  year,  almost  a 
year. 


1041 

Senator  Kennedy.  Did  you  receive  any  compensation  for  this  ? 

Mr.  Scott.  I  was  away  up  in  Ohio.  At  the  time  they  wrote  a  letter 
to  my  sister  and  they  sent  $25.  They  said  it  was  for  the  study,  with 
Miss  Rivers. 

Senator  Kennedy.  Is  that  the  first  time  that  you  knew  you  were 
involved  in  a  study  ? 

Mr.  Scott.  I  was  involved  in  it  before  I  left.  This  time,  this  study 
now,  I  got  involved  through  Miss  Rivers,  I  believe  it  was. 

Senator  Kennedy.  What  did  you  think  they  were  giving  the  shots 
for? 

Mr.  Scott.  Bad  blood. 

Senator  Kennedy.  They  just  told  you  it  was  for  bad  blood? 

Mr.  Scott.  Yes. 

Senator  Kennedy.  Did  you  think  the  shots  were  making  you  better? 

Mr.  Scott.  I  thought  they  would  at  that  time. 

Senator  Kennedy.  Is  that  what  the  doctor  told  you  who  gave  you 
the  shots  ? 

Mr.  Scott.  Yes.  He  told  me  it  was  for  bad  blood. 

Senator  Kennedy.  And  sometime  later  you  got  the  $25  ? 

Mr.  Scott.  Yes.  It  was  six  or  seven  years  after  I  left. 

Senator  Kennedy.  Did  you  get  a  certificate  of  appreciation,  too  ? 

Mr.  Scott.  No,  I  did  not. 

Senator  Kennedy.  But  you  heard  that  some  of  the  others  got  it. 

How  did  you  feel  after  you  read  in  the  newspapers  that  you  had 
been  involved  in  this  kind  of  study  or  experiment?  Did  that  bother 
you  at  all  ? 

Mr.  Scott.  Well,  not  too  much  at  that  time  because  I  was  thinking 
of  my  health,  figuring  they  were  doing  me  good.  So  I  didn't  think  too 
much  of  it.  I  thought  it  would  be  all  right. 

And  then  when  this  study  came  along.  I  don't  think  much  of  it 
because  I  think  they  were  just  using  me  for  something  else,  as  an 
experiment. 

Senator  Kennedy.  Do  you  think  that  is  right  ? 

Mr.  Scott.  No,  I  don't  think  that  is  right. 

Senator  Kennedy.  Do  you  think  they  should  have  told  you  about  it  ? 

Mr.  Scott.  I  think  they  should  have  told.  If  they  had  told,  I  would 
have  resorted  to  a  family  doctor  or  some  other  doctor. 

Senator  Kennedy.  You  would  have  gone  to  your  family  doctor  and 
got  treated  ? 

Mr.  Scott.  Yes. 

Senator  Kennedy.  You  thought  you  were  being  treated  ? 

Mr.  Scott.  I  thought  I  was  being  treated  then. 

Senator  Kennedy.  And  you  were  not? 

Mr.  Scott.  I  was  not. 

Senator  Kennedy.  That  is  not  right,  is  it  ? 

Mr.  Scott.  No,  it  is  not  right. 

Senator  Kennedy.  What  do  you  think  the  Government  ought  to 
do  now  ? 

Mr.  ScoT'r.  I  think  the  Government  ought  to  do  something  as  they 
were  using  us.  They  ought  to  give  us  compensation  or  something  like 
that,  where  we  can  see  other  doctors  and  continue  our  health.  That  is 
what  I  think. 


1042 

Senator  Kennedy.  You  want  to  make  sure  that  the  next  time  you 
see  a  Government  doctor  that  he  is  treating  you  to  get  you  better. 

INIr.  Scott.  That  is  right. 

Senator  Kennedy.  That  is  what  you  want. 

Mr.  Scott.  And  I  can  be  sure  I  go  to  the  right  doctor. 

Senator  Kennedy.  What  about  you,  Mr.  Pollard  ?  What  would  you 
like? 

Mr.  Pollard.  This  I  read  in  the  paper  I  don't  want  no  parts  of  it. 

I  was  fixing  to  say  I  was  booked  to  go  to  Birmingham  when  this 
penicillin  come  out,  but  the  nurse  told  me  I  wasn't  able  to  go  up  there. 
So  they  turned  me  down.  I  don't  want  no  more  part  of  it. 

Senator  Kennedy.  Mr.  Scott  and  Mr.  Pollard,  when  you  were  talk- 
ing to  these  doctors  that  were  giving  you  these  shots,  did  they  ever 
suggest  to  you  or  recommend  to  you  that  you  not  have  a  family  ? 

Mr.  Scott.  No,  they  did  not. 

Mr.  Pollard.  Not  what  ?  f 

Senator  Kennedy.  Not  have  a  family.  Did  they  ever  recommend  to 
you  that  you  not  have  a  family  ? 

Mr.  Pollard.  No,  they  never  said  anything  about  that. 

Senator  Kennedy.  They  never  mentioned  that  ? 

Mr.  Pollard.  No. 

Senator  Kennedy.  Mr.  Gray,  have  you  any  further  comments? 

Mr.  Gray.  I  would  simply  like  to  say,  Senator  Kennedy,  on  behalf 
of  these  participants  we  certainly  want  to  express  our  genuine  appre- 
ciation for  being  able  to  come.  At  least  now  this  committee  knows  the 
views  of  the  participants,  and  we  certainly  hope  that  this  subcommit- 
tee and  the  Congress  will  take  appropriate  action  to  see  that  these 
people  are  adequately  compensated. 

Thank  you. 

Senator  Kennedy.  I  want  to  thank  you  very  much  for  coming.  As 
you  know  several  months  ago,  some  four  months  ago,  the  Department 
of  HEW  indicated  that  they  were  going  to  move  on  this  to  try  and 
remedy  or  rectify  the  situation. 

The  commission  met  on  March  1  and  indicated  that  still  there  had 
been  no  care  forthcoming.  We  had  another  commitment  pledge  by  the 
Secretary  that  there  would  be  action.  I  want  to  indicate  to  you  that  we 
are  going  to  make  sure,  as  far  as  the  power  of  this  Senate  Subcommit- 
tee, that  there  will  be  help  and  assistance  and  care  for  all  of  those  in- 
dividuals. 

It  is  absolutely  an  outrageous  and  intolerable  situation  which  this 
Government  never  should  have  been  involved  in.  That  is  bad  enough, 
but  we  are  going  to  do  everything  in  our  power  to  work  with  Mr.  Pol- 
lard and  Mr.  Scott,  and  all  of  the  others  who  still  need  the  help,  and 
the  heirs  of  the  others  as  well. 

T  want  to  give  those  assurances  to  you,  Mr.  Pollard  and  Mr.  Scott.  We 
will  look  forward  to  working  with  you. 

Mr.  Gray.  We  have  waited  really,  Senator,  about  nine  months  on  the 
Government  to  take  some  action  before  we  would  take  any  legal  ac- 
tion. The  Government  simply  moves  very  slowly  and  time  is  beginning 
to  mn  out  on  us. 

Thank  you. 

Senator  Kennedy.  We  are  going  to  stay  after  it  and  we  will  work 
with  vou. 


1043 

I  want  to  thank  both  of  you  gentlemen  for  your  appearance  here, 
for  your  wilhngness  to  share  with  us  your  experience.  It  has  been  very, 
very  helpful. 

We  are  going  to  have  as  our  next  witness  Dr.  Barber,  of  Barnard 
College.  He  is  Chairman  of  the  Sociology  Department  and  a  member  of 
the  graduate  faculty  of  Columbia.  He  has  been  a  member  of  the  Drug 
Research  Board  of  the  National  Academy  of  Sciences.  He  is  a  member 
of  the  Human  Subjects  Review  Committee  at  Columbia. 

Dr.  Barber. 

STATEMENT  OF  PROF.  BERNARD  BARBER,  CHAIRMAN,  DEPART- 
MENT OF  SOCIOLOGY,  BARNARB  COLLEGE,  COLUMBIA  UNI- 
VERSITY 

Mr.  Barber.  Thank  you  for  the  opportunity,  Mr.  Chairman,  to  make 
a  statement  on  the  problems  of  human  experimentation. 

After  what  we  have  just  heard  from  the  two  Tuskegee  subjects,  I 
hardly  need  to  say  this  is  an  important  social  problem,  and  I  hope  my 
statement  will  be  of  some  help  to  you  in  devising  legislation  for  the 
improvement  of  standards  and  practices  in  this  area. 

May  I  say  just  a  few  words,  first,  about  my  experience  with  this  mat- 
ter? As  a  sociologist,  I  have  been  concerned  with  the  problems  of  med- 
icine, the  professions,  and  science  during  my  whole  professional  career. 

As  a  result  of  this  long-standing  concern,  I  have  written  several 
books  and  articles  on  these  problems.  More  recently,  during  the  last  4 
years,  together  with  my  colleagues — John  Lally,  Julia  Loughlin  Maka- 
rushka,  and  Daniel  Sullivan — I  have  been  engaged  in  intensive  re- 
search on  the  ethics  of  human  experimentation. 

With  support  from  the  Russell  Sage  Foundation,  my  colleagues  and 
I  have  done  two  studies :  One  on  a  nationally  representative  sample  of 
292  biomedical  research  institutions  using  human  subjects;  the  second 
on  a  sample  of  350  research  physicians  using  human  subjects  in  tw^o  in- 
stitutions, one  we  called  University  Hospital  and  Research  Center,  the 
other  Community  and  Teaching  Hospital,  two  typical  institutions. 

Confidentiality  w^as,  of  course,  guaranteed  all  our  respondents.  Fi- 
nally, during  the  years  1966-70, 1  was  a  member  of  the  Drug  Research 
Board,  National  Academy  of  Sciences — National  Research  Council, 
and  had  many  occasions  during  that  service  to  discuss  with  my  med- 
ical colleagues  on  the  Board  and  with  the  Commissioner  of  the  Food 
and  Drug  Administration  some  of  the  problems  before  you  in  your 
present  hearings. 

I  have  been  asked  to  limit  myself  to  telling  you  about  only  two  of  the 
several  sets  of  facts  that  came  out  in  the  research  that  we  have  done 
during  the  last  4  years.  Our  full  and  final  report  can  be  seen  in  Barber^ 
et  al.  Research  on  Hnm^n  Subjects:  Problems  of  Social  Control  on 
Medical  Expemmeritation.  New  York :  Russell  Sage  Foundation,  1978. 

One  is  about  the  differential  treatment  of  types  of  patient-subjects 
in  our  two  hospitals.  The  other  is  about  the  actual  efficacy  of  the  peer 
review  committees,  which  were  mandated  by  NTH  in  1966. 

When  we  asked  our  350  physician-researchers,  Avho  were  altogether 
involved  in  424  different  studies  using  human  subjects,  to  estimate  how 
much  benefit  their  studies  had  for  the  subjects,  how  much  risk,  how 
much  possible  benefit  for  future  patients,  and  how  much  scientific 


1044 


value,  what  they  themselves  told  us  showed  that  18  percent  of  the 
studies  involved  more  risk  than  benefit  for  present  subjects. 

Senator  Kennedy.  How  can  they  get  by  in  a  university  review  com- 
miftee  with  18  percent  ? 

^Ir.  Barber.  I  don't  know  the  details  of  that.  I  think  one  of  the  most 
urgent  studies  is  for  somebody  actually  to  be  sitting  in  on  these  review 
committees  and  finding  out  what  is  actually  going  on.  We  don't  know 
what  is  actually  going  on  in  review  committees. 

I  will  say  a  little  more  later  on  about  some  of  the  conditions  which  I 
think  are  inadequate  for  efficacious  review.  Some  of  these  less  favorable 
studies  were  said  to  promise  benefits  to  future  patients,  but  even  when 
these  future  benefits  were  thrown  into  the  balance,  there  were  still  eight 
percent  of  the  studies  that  involved  more  risk  than  benefit. 

Since  these  are  the  researchers'  own  estimates,  remember,  it  is  not 
unlikely  that  at  least  some  small  underestimation  of  risks,  some  over- 
estimation  of  benefits  is  involved. 

But  this  eight  percent  of  the  studies,  what  we  called  the  "least  favor- 
able" studies,  were  not  carried  out  at  random  on  types  of  patient- 
subjects.  We  also  had  asked  our  researchers  to  tell  us  the  relative  pro- 
portions of  private  and  ward  or  clinic  patients  used  on  each  study. 

Using  this  information,  we  found  that  studies  where  the  risks  are 
relatively  high  in  proportion  to  therapeutic  benefits  for  subjects  are 
almost  twice  as  likely  to  be  done  using  subjects  more  than  three-fourths 
of  Avhom  are  ward  or  clinic  patients. 

Even  when  we  put  the  benefits  to  future  patients  and  possible  benefit 
to  medical  knowledge  into  the  balance,  we  still  found  that  the  "least 
favorable"  studies  were  almost  twice  as  likely  to  be  done  on  ward  or 
clinic  patients.  These  are  the  people,  as  you  have  just  seen  in  your 
conversation  with  the  two  Tuskegee  subjects,  least  likely  to  understand 
a  study  in  order  to  give  informed  consent.  They  are  less  knowledgeable 
about  how  hospitals  are  organized  and  about  what  goes  on  in  them 
other  than  patient  care.  In  sum,  they  are  least  likely  to  know  how  to 
protect  themselves. 

Now,  a  brief  account  of  our  findings  about  the  efficacy  of  the  peer 
review  committees.  Our  study  of  the  sample  of  292  medical  research  in- 
stitutions which  had  given  an  assurance  of  compliance  to  NIH  for  its 
regulations  on  human  subjects  showed  that  only  86  percent  of  them 
reviewed  all  research.  Nine  percent  still  did  not  review  research  that 
was  not  contained  in  a  formal  research  proposal,  and  four  percent  re- 
ported that  they  reviewed  only  research  propsals  that  they  submitted 
to  NIH  for  funding. 

Moreover,  in  our  intensive  interview  study  of  850  medical  research- 
ers who  were  in  two  institutions  that  supposedly  review  all  research, 
nine  percent  of  the  respondents  volunteered  the  information  that  they 
were  doing  research  that  had  not  been  peer  reviewed. 

And  even  where  peer  review  has  been  carried  out,  our  studies  show, 
some  of  it  is  not  being  done  under  mandated  or  what  we  roughly  de- 
fined as  the  most  efficacious  of  conditions. 

For  example,  there  is  a  lack  of  mandated  continuing  review  in  many 
institutions;  there  is  a  lack  of  face-to-face  discussion  and  moral  con- 
frontation among  the  reviewers;  and  there  is  an  absence  of  appeal 
procedures. 


1045 

The  committees  in  the  several  separate  institutions  are  not  in  touch 
with  one  another  and  are  therefore  without  benefit  of  pooled  experi- 
ence, and  I  should  add,  benefit  of  pooled  moral  indignation. 

With  regard  to  efficacy,  moreover,  our  data  show  that  medical 
school  j>eer  review  committees,  where  one  would  expect  excellence,  are 
no  better  than  committees  in  other  types  of  research  institutions. 

I  would  like  to  finish,  as  requested,  with  a  few  recommendations  to 
the  committee.  First,  I  very  strongly  recommend  that  there  be  Federal 
legislation  for  control  of  the  use  of  humans  in  all  medical 
experimentation. 

The  biomedical  research  profession  has  simply  failed  to  take  the 
initiative  in  effective  self-regulation  in  this  area.  It  was  laggard  in 
setting  up  peer  review  committees  before  1966  audit  was  only  Govern- 
ment action  then  in  the  form  of  NIH  regulation  that  resulted  in  the 
improvement  that  has  occurred  during  these  last  five  years. 

But,  in  this  recent  period,  there  has  been  no  sign  of  the  kind  of 
intensive,  imaginative,  coordinated,  persisting  action  with  regard  to 
the  ethics  of  experimentation  that  the  biomedical  research  profession 
has  displayed  in  advancing  the  cause  of  medical  research  and  therapy. 
Science  is  still  put  somewhat  before  the  ethical  concern  for  the  prob- 
lems that  science  creates. 

We  say  this  point  clearly  in  some  of  our  other  data.  When  we  asked 
the  350  researchers  to  name  a  set  of  three  characteristics  they  valued  in 
potential  research  collaborators,  86  percent  of  the  researchers  men- 
tioned "scientific  ability",  45  percent  mentioned  "hard  work",  43  per- 
cent mentioned  "personality",  but  only  six  percent  mentioned  "ethical 
concern  for  research  subjects". 

Nevertheless,  though  I  recommend  Government  legislation,  I  am 
'  convinced  that  a  satisfactory  system  of  ethical  controls  in  this  area 
will  result  only  from  the  wholehearted  and  knowledgeable  participa- 
tion of  the  biomedical  research  profession. 

Government  legislation  should  not  be  defined  as  negative  and  puni- 
tive, therefore,  but  as  calling  medical  researchers  to  their  self- 
professed  values  and  providing  them  with  guidelines  and  mechanisms 
for  more  satisfactoi-y  performance. 

In  the  legislation  that  I  recommend,  I  would  like  to  see  provision  for 
the  establishment  of  a  National  Board  of  Biomedical  Research  Ethics. 
As  members  of  that  Board  I  would  like  to  see  not  only  members  of  the 
medical  research  profession,  who  are  of  course  indispensable,  but  also 
people  who  are  outsiders  to  the  profession  and  who  represent  the 
public. 

These  outsiders  cannot  be  ordinary  men-in-the-street  or  men  given  to 
absolute  morals;  they  should  be  informed  outsiders,  lawyers  or  social 
scientists,  qr  men  of  affairs,  who  have  the  expertise  or  experience  to 
deal  with  the  fact  that  medical  research  ethics  are  also  social  and  not 
just  medical  matters. 

If  war  is  too  important  to  be  left  to  a:enerals,  so  medical  research  is 
now  much  too  important  to  be  left  to  the  professionals  in  that  field. 

Buildinjr  on  the  cfood  detailed  res^ulations  presently  promulgated  by 
NIH-DHEW,  the  Board  could  define  goals,  establish  institutions  and 
mechanisms,  and  provide  necessary  monitoring  for  standards  and 
practices  that  are  only  what  the  profession  rightly  values  and  the  pub- 
lic increasingly  and  rightly  demands. 


93-999  O  -  73  -  pt.   3  --  17 


1046 

That  is  the  end  of  my  statement,  Mr.  Chairman.  I  would  be  glad  to 
answer  questions  or  amplify  my  remarks. 
Senator  Kennedy.  That  is  a  very  good  statement.  1 

What  has  been  the  reaction  of  the  research  community  to  the  sug- 
gestion of  yours  about  the  National  Bciird  of  Biomedical  Research 
Ethics? 

"Wliat  has  been  your  feedback  from  the  research  community  on  this 
suggestion  ? 

Mr.  Barber.  I  haven't  made  that  suggestion  specifically.  Our  book 
has  just  appeared.  I  have  made  it  in  several  of  the  talks  t  have  given 
so  far.  There  are  a  few  people  in  the  medical  community  who  are  con- 
cerned about  these  problems,  but  on  the  whole  it  s^ems  to  me,  as  I  said, 
that  there  is  not  the  kind  of  close,  energetic  and  imaginative  attention 
being  paid  to  these  problems  by  people  in  the  medical  research  profes- 
sion that  there  rightly  should  be. 

I  think  the  medical  research  profession  tends  to  be  made  up  of  very 
able  and  highly  individualistic  men  who  are  likely  to  resist  what  they 
define  as  outside  control. 

My  suggestion  to  them  is  not  to  define  this  as  outside  control,  but  to 
define  this  as  a  mechanism  by  which  they  could  participate,  as  they 
rightly  should,  with  members  of  the  general  public  to  follow,  as  I  say, 
only  tiie  values  that  they  presently  profess. 

Senator  Kennedy.  What  is  the  motivation  of  researchers  who  con- 
duet  research  in  which  the  risks  to  the  patient  will  exceed  the  potential 
benefit  ?  What  is  the  basis  for  that  motivation  ? 

Mr.  Barber.  One  of  the  findings  we  haven't  told  you  about  is  con- 
cerned with  a  problem  we  call  the  dilemma  of  science  and  therapy. 
We  feel  that  there  are  two  strong  values  here.  One  is  science,  that  is, 
being  successful  as  a  scientist,  and  the  other  very  genuinely  is  the  value 
of  humane  therapy. 

In  most  cases  it  is  easy  to  accommodate  these  two  values  and  scien- 
tists so  do.  Apparently  in  some  cases  the  therapy  is  put  before  the 
science.  There  are  some  people  who  refuse  to  do  the  research. 

But  in  other  cases,  our  data  show,  there  are  some  scientists  who  are, 
by  inference,  putting  the  science  ahead  of  the  therapy. 

We  have  what  we  call  extreme  mass  producers,  people  who  are  rela- 
tive failures  in  science,  as  judged  by  the  prestige  they  are  getting  from 
their  colleagues,  who  are  more  likely  to  be  doing  these  more  permissive 
studies. 

We  did  not  have  data  on  another  kind  of  case  where  science  and 
therapy  comes  into  conflict,  but  that  is  a  case  that  has  been  treated  in 
the  press.  I  am  convinced  that  very  distinguished  scientists,  who  are 
very  visibly  in  competition  with  each  other,  people  like  DeBakey  and 
Cooley,  also  get  into  situations  of  this  kind  sometimes. 

Senator  Kennedy.  Your  observation  is  that  riskier  studies  are  apt  to 
be  done  to  poor  or  minority  group  patients. 

Mr.  Barber.  I  would  like  to  stress  only  one  point  here.  There  is  al- 
ways, I  think,  the  added  factor  of  discrimination  against  the  blacks, 
probably.  But  I  would  like  it  to  be  seen  in  the  broader  context. 

It  seems  to  me  a  good  part  of  the  discrimination  here  against  the 
blacks  is  because  they  are  poor.  The  poor  generally  in  the  hospitals  are 
treated  this  way. 

Senator  Kennedy.  Poor  white,  poor  black,  poor  Mexican-Ameri- 
cans. Just  poor. 


1047 

Mr.  Barber.  That  is  right. 

Senator  Kennedy.  You  are  not  surprised  that  this  is  the  same  kind 
of  situation  that  we  find  in  drug  experimentation.  It  is  the  same  kind 
that  we  see  across  the  board. 

Mr.  Barber.  Sometimes  when  we  report  this  result  to  our  medical 
colleagues,  they  say,  "Yes,  of  course.  We  know  that."  They  seem  to 
think  it  is  the  larger  system.  My  own  feeling  is  that  there  is  some  part 
of  the  responsibility  that  belongs  to  the  medical  profession  as  well  as 
to  the  more  general  political  process,  for  seeing  to  it  that  the  system  is 
not  discriminatory  in  this  way. 

Senator  Kennedy.  Would  you  talk  just  a  little  bit  about  the  effec- 
tiveness of  peer  review  in  university  settings?  How  effective  is  peer 
review?  WTiat  has  been  your  evaluation?  I  am  sure  there  are  some 
excellent  examples  and  some  poor  ones  and  some  in  between.  But  can 
you  give  us  anything  more  on  what  your  studies  have  shown  ? 

Mr.  Barber.  We  have  always  tried  to  be  scientific  about  this  and  to 
lean  over  backwards  about  making  statements  of  this  kind.  I  really 
must  insist  that  we  don't  have  anv  solid  and  large  evidence. 

Dr.  Katz,  whom  you  will  hear  from  shortly,  and  I  have  been  talking 
the  last  couple  of  days  and  suggesting  that  a  very  desirable  kind  of 
study  for  the  immediate  future  would  be  systematically  to  see  what  the 
review  committees  are  actually  doing. 

But,  as  I  suggested,  it  seems  to  me  our  data  indicate  a  number  of 
deficiencies.  There  is  not  effective,  continuing  review. 

Senator  Kennedy.  Let  me  interrupt.  If  we  do  pass  something,  do 
you  think  this  would  be  upgraded,  if  we  show  that  we  mean  business 
about  this  ? 

Mr.  Barber.  It  could  set  goals,  it  could  provide  some  of  the  kinds  of 
information.  Some  of  this  has  been  done  by  the  people  in  the  Institu- 
tional Relation  Section  of  NIH,  but  that  should  all  have  been  much 
more  heavily  staffed  and  should  have  been  raised  to  a  position  of  much 
greater  importance  than  it  has  been. 

For  example,  I  think  even  in  NIH-DHEW  it  should  at  least  have 
been  at  the  Assistant  Secretary  level.  Also,  Dr.  Katz  and  I  tend  to 
agree  that  the  National  Board  should  not  be  in  DHEW  because 
DHEW  is,  in  effect,  a  party  at  interest  in  this  problem,  and  the  Board 
should  have  an  independence  even  from  them. 

Senator  Kennedy.  Thank  you  very  much.  Senator  Mondale  will 
assume  the  Chair. 

Senator  Mondale  (presiding  pro  tempore).  For  5  years  now  I 
have  been  introducing  a  bill  to  establish  a  Commission  on  Health 
Science  and  Society,  solely  for  the  purpose  of  studying  some  of  the 
ethical  questions  you  have  raised. 

I  was  not  here  for  your  testimony,  but  I  understand  what  you  are 
saying  is  what  we  now  know  should  take  us  beyond  a  study,  into 
some  kind  of  commission  which  could  police  or  regulate  dangerous 
experimentation. 

Do  I  understand  you  correctly  ? 

Mr.  Barber.  I  would  qualify  that  in  only  one  way.  I  don't  like  the 
word  "police".  To  monitor,  guide,  set  standards. 

I  have  the  feeling  that  part  of  the  trouble  is  that  people  are  not 
facing  up  to  their  own  standards  here. 

Senator  Mondale.  The  answer  is  always  peer  review.  You  say  that 
the  literature  shows  that  peer  review  is  not  working  the  way  it  should. 


1048 

Mr.  Barber.  It  could  work  more  efficaciously,  I  think,  especially  if 
a  number  of  conditions  were  changed.  For  example,  in  many  places 
I  think  people  are  not  sitting  down  and  looking  each  other  in  the  eye 
and  asking,  "Do  we  really  want  this  done  V 

They  call  each  other  on  the  telephone  and  each  fellow  says,  "I  don't 
want  to  rock  the  boat.  We  will  let  that  study  through."  That  is  a  possi- 
bility. 

Senator  Mondale.  The  AMA  flew  Christiaan  Barnard  all  the  way 
from  South  Africa  to  tell  us  how  horrible  it  would  be,  to  put  a  police- 
man into  every  institution.  Is  Dr.  Barnard  that  wrong  ? 

Mr.  Barber.  Yes,  I  am  afraid  he  is  that  wrong.  There  are  a  variety 
of  alternatives.  First  of  all,  I  think  we  need  some  better  knowledge. 
One  of  the  phrases  I  stressed  in  my  statement  is  that  we  need  more 
wholehearted  and  knowledgeable  participation  from  the  biomedical 
research  profession.  By  knowledgeable,  I  mean  something  of  the  fol- 
lowing kind,  another  finding  which  I  haven't  reported.  It  comes  from 
our  study  of  how  doctors  are  trained  in  medical  schools. 

Let  me  give  you  that  very  briefly.  When  we  asked  people  if  they  had 
had  any  course  or  training  in  the  problem  of  the  ethics  of  research,  we 
found  that  only  13  percent  had  so  much  as  a  seminar  or  lecture  or 
part  of  a  course  on  the  ethical  problems  of  experimentation. 

These  are  overlapping  types  of  percentages.  Another  13  percent 
said  as  students  they  thought  about  ethics  when  they  did  practice 
procedures  on  one  another.  Twenty -four  percent  said  that  they  thought 
about  these  problems  when  they  were  doing  training  procedures  on 
animals.  Thirty-five  percent  said  they  learned  about  ethics  in  discus- 
sions with  instructors  or  other  students.  But  57  percent  of  our  people 
mentioned  not  a  single  one  of  these. 

So  way  back  in  medical  school  the  physicians  are  not  being  properly 
trained. 

Senator  Mondale.  Do  you  think  a  study  of  ethics  would  change  the 
practices  ? 

Mr.  Barber.  That  would  be  one  of  the  essential  things. 

Senator  Mondale.  We  have  an  ethics  course  in  law  school. 

Mr.  Barber.  I  am  not  suggesting  that  is  the  only  thing,  but  I  do 
think  one  starts  there.  I  think  it  would  be  unfair  to  the  medical  pro- 
fession not  to  see  that  this  is  a  profession  that  professes  certain  values. 

Senator  Mondale.  Is  there  any  parallel  for  your  proposal  in  other 
countries,  which  have  arrangements  somewhat  like  what  you  are 
suggesting  ? 

Mr.  Barber.  I  have  looked  into  that  matter.  I  received  a  letter  from 
the  World  Health  Organization  which  points  out  that  there  is  not  in 
a  single  other  cotintry  in  the  world  with  even  the  present  NIH-DHEW 
regulations. 

I  know  that  in  England  there  is  a  system  of  voluntary  panels  set 
iip  by  the  Royal  College  of  Physicians,  and  I  happen  to  know  also  as 
a  consultant  to  groups  which  give  funding  abroad  that,  if  anything, 
the  situation  is  much  worse  abroad.  There  the  physician  is  much  more 
authoritative,  much  more  individualistic,  much  less  subject  to  control. 

Senator  Mondale.  A  few  years  ago  some  of  us  suggested  that  there 
ought  to  be  a  required  course  in  medical  schools  of  ethical  and  economic 
implications  of  medicine,  so  they  would  be  required  to  study  the  kind 
of  issues  you  ?ire  talking  about,  plus  the  relationship  between  their 
practice  of  their  profession  and  society. 


1049 

Does  that  make  some  sense  to  you  ? 

Mr.  Barber.  As  one,  as  I  say,  of  the  parts  of  what  I  think  are  the 
changes  that  need  to  go  toward  improvement.  There  are  some  courses 
now  being  instituted  to  try  to  include  ethical  training,  not  so  much  in 
the  old  lecture  courses,  but  actually  as  an  ongoing  part  of  the  clinical 
training,  as  an  attempt  to  communicate  ethical  problems  and  ethical 
responses  just  as  the  actual  therapy  and  clinical  investigations  are 
being  carried  out.  Something  of  that  kind,  it  seems  to  me,  would  be 
much  more  desirable. 

I  would  insist  that  part  of  the  trouble  is  the  sheer  lack  of  awareness 
and  attention  and  knowledge.  It  seems  to  me  that  broadly  speaking, 
the  biomedical  research  profession  has  been  so  busy  paying  attention 
to  science  and  some  of  its  marvelous  new  therapeutic  techniques  that 
it  has  not  paid  sufficient  attention  to  these  other  matters.  They  have 
sort  of  lagged,  and  I  think  there  now  needs  to  be  an  adjustment. 

Senator  Mondale.  Thank  you  very  much.  Our  next  witness  is  Dr. 
Jay  Katz  of  the  Yale  University  School  of  Law. 

STATEMENT  OF  JAY  KATZ,  M.B.,  YALE  UNIVERSITY  SCHOOL  OP 

LAW 

Dr.  Katz.  I  have  studied  the  problems  posed  by  research  with 
human  beings  for  many  years  and,  I  am  convinced  that  the  regula- 
tions governing  human  experimentation  must  be  fundamentally  re- 
structured. Before  presenting  to  you  my  recommendations  for  reform, 
I  would  like  to  make  a  number  of  observations  in  order  to  place  my 
proposals  in  context. 

Twenty-eight  years  have  passed  since  the  Nuremberg  trials  of  the 
Nazi  physicians  accused  of  conducting  medical  experiments  in  con- 
centration camps  with  unnecessary  suffering,  injury  and  cruelty.  At 
the  time  of  the  trials  a  distinguished  group  of  American  and  European 
investigators  testified  that  such  violations  of  Hippocratic  command- 
ments could  not  have  occurred,  even  on  a  less  extensive  scale,  in  the 
United  States  or  elsewhere  in  the  civilized  world  and  that  the  Nurem- 
berg Code,  promulgated  by  the  judges  of  the  Military  Tribunal,  not 
only  set  forth  the  conditions  which  should  govern  the  conduct  of  future 
research  but  also  expressed  the  basic  principles  which  had  always 
been  adhered  to  by  the  vast  majority  of  researchers. 

Even  a  cursory  review  of  the  history  of  human  experimentation 
would  have  contradicted  these  views.  And  since  these  trials  we  have 
lived  through  the  thalidomide  tragedy,  the  Jewish  Chronic  Disease 
Hospital  "cancer"  injection  case,  the  Tuskegee  syphilis  study,  the  dis- 
closures of  unethical  experimentation  presented  by  Dr.  Henry  K. 
Beecher,  and  countless  other  experiments  with  prisoners,  children  and 
patients  that  violate  the  principles  of  the  Nuremberg  Code. 

The  conscious  and  unconscious  denial  of  widespread  transgressions 
has  many  roots  which  I  cannot  discuss  today ;  suffice  it  to  say  that  the 
research  community  has  made  no  concerted  effort  either  to  impose 
any  meaningful  self-regulation  on  its  practices  or  to  discuss  in  any 
scholarly  depth  the  permissible  limits  of  human  research.  Therefore, 
T  submit,  regulation  has  to  come  from  elsewhere. 


1050 

In  1966  the  U.S.  Public  Health  Service  (USPHS)  and  five  years 
later  the  Department  of  Health,  Education,  and  Welfare  (DHEW) 
formulated  policies  for  the  protection  of  human  subjects  involved  in 
research.  Opponents  of  any  additional  regulation  of  human  experi- 
mentation will  assert  the  adequacy  of  the  safeguards  which  have  now 
been  introduced. 

Though  the  USPHS  and  DHEW  policies  have  provided  some  sig- 
nificant controls  over  research  practices,  I  submit  that  they  are  in- 
adequate and  that  the  problems  remain  unsolved.  Before  giving 
support  to  my  conclusion,  let  me  note  briefly  that  neither  the  USPHS 
nor  DHEW  have  addressed  themselves  with  sufficient  seriousness  of 
purpose  to  the  implementation  of  the  primary  intent  of  their  policies — 
the  protection  of  human  subjects. 

A  reading  of  the  transcripts  of  the  committee  meetings  held  prior  to 
the  establishment  of  the  current  regulations  suggests  that  there  was 
all  to  little  concern  with  giving  greater  protection  to  research  subjects, 
and  much  preoccupation  with  protecting  the  agencies  from  judicial 
and  congressional  criticism,  if  anything  should  go  wrong  with  a  re- 
search project  they  had  funded. 

During  these  earlier  meetings  little,  if  any,  attention  was  paid  to 
the  problem  of  establishing  criteria  for  "ethical'*  research,  and  one  of 
the  lay  members  observed  with  perspicacity,  and  I  assume  also  with 
exasperation,  "You  cannot  tell  people  to  do  the  right  thing  without 
telling  them  wiiat  the  right  thing  is." 

Moreover,  the  staff  assigned  to  and  the  funds  provided  for  main- 
taining ethical  standards  of  research  for  Government-supported  in- 
vestigations is  and  has  always  been  woefully  inadequate.  Finally,  the 
regulations  for  intramural  research  are  less  stringent  that  for  extra- 
mural research  grants,  a  curious  fact  which  requires  explanation. 

Current  DHEW  policies  vest  primary  responsibility  for  the  pro- 
tection of  research  subjects  in  institutional  review  committees;  over 
600  such  committees  are  presently  in  existence.  In  carrying  out  their 
functions  the  review  committees  are  instructed  to  follow  the  guidelines 
provided  by  DHEW. 

Tliese  guidelines  not  only  are  inadequate  but  also  impose  on  each 
individual  review  committee  the  formidable  task  of  interpreting  and 
giving  substance  to  vague  and  all  too  general  governing  standards. 
This,  to  my  knowledge,  few  review  committees  have  done.  Moreover, 
the  review^  committees  work  in  isolation  from  one  another,  and  no 
mechanisms  have  been  established  for  disseminating  whatever  knowl- 
edge is  being  gained  from  their  individual  experiences. 

Thus,  each  committee  is  condemned  to  repeat  the  process  of  finding 
its  own  answers.  This  is  not  only  an  overwhelming,  unnecessary  and 
unproductive  assignment,  but  also  one  which  most  review  committees 
are  neither  prepared  nor  willing  to  assume. 

Let  me  illustrate  a  few  of  the  problems  posed  by  the  DHEW  poli- 
cies :  The  guidelines  state  that  "the  risks  to  an  individual  [must  be] 
outweighed  by  the  potential  benefit  to  him  or  by  the  importance  of  the 
knowledge  to  be  gained."  The  seeming  simplicity  of  this  command 
belies  its  complexity. 

How  are  such  intangibles  as  "risks,"  "benefits,"  and  "importance  of 
knowledge"  to  be  measured  and  weighed  in  the  different  research  con- 
texts in  which  they  can  arise?  Can  serious  harm  to  research  subjects 


1051 

ever  be  outweighed  solely  by  additions  to  the  sum  of  human  knowledge  ? 

If  so,  must  for  example,  certain  groups,  such  as  children  and  men- 
tally defective  subjects,  be  excluded  from  all  risky  studies,  and  does 
it  make  a  difference  whether  these  studies  are  or  are  not  designed  to 
benefit  them  directly  ? 

Do  even  minimal  risks,  created  by  participation,  require  an  intensive 
scrutiny  of  the  benefits  to  be  derived  from  the  study,  or  should  "min- 
mal"  risks,  however  defined,  be  exempted  from  such  a  burdensome  re- 
quirement ?  How  often  can  risky  experiments  be  repeated  for  the  sake 
of  verification,  if  results  have  already  been  reported  in  the  literature  ? 

In  research  with  normal  volunteers  or  other  subjects  who  are  able  to 
give  a  "satisfactory"  consent  to  risks,  can  greater  risks  be  taken  with 
them  than  a  weighing  of  risks  against  benefits  would  permit  with  other 
research  participants?  Should  dying  patients,  willing  to  participate 
in  risky  experiments,  be  exempted  from  the  restriction  that  no  experi- 
ments be  conducted  which  might  hasten  death  ? 

If  the  requirement  of  informed  consent  is  to  be  taken  seriously 
should  socially  and  economically  impoverished  or  uneducated  persons 
ever  be  selected  as  subjects  for  research  ?  Should  not  a  concerted  effort 
first  be  made  to  find  subjects  among  the  most  educated  within  the 
population  at  large,  or  at  least  to  select  from  a  given  group  those  sub- 
jects who  are  most  capable  of  giving  their  "informed  consent?" 

Put  more  generally,  what  basic  principles  should  guide  the  selection 
of  subjects  ?  The  philosopher  Rans  Jonas  has  given  one  answer  to  the 
questions:  "[0]ne  should  look  for  [subjects]  among  the  most  highly 
motivated,  the  most  highly  educated,  and  the  least  'captive'  members 
of  the  community." 

Before  making  one  final  observation,  allow  me  merely  to  flag  some  of 
the  issues  which  the  DHEW  policies  do  not  address  and  which  are  thus 
left  for  the  Institutional  Review  Committees  to  resolve:  (1)  The  use 
of  prisoners  for  research  purposes  which,  as  I  understand,  is  a  more 
widespread  practice  in  the  United  States  than  elsewhere  in  the  world. 

Queries:  Should  prisoners  be  allowed  to  participate  in  research  as 
extensively  as  they  now  do  ?  If  so,  what  impact  do  such  practices  have 
on  the  administration  of  justice  ?  Should  prisoners  be  permitted  to  par- 
ticipate in  research  only  in  proportion  to  noncaptive  subjects  selected 
for  similar  purposes  ? 

Should  particularly  dangerous  experiments  ever  be  performed  on 
prisoners?  (2)  The  participation  of  children  in  research^  especially 
institutionalized  children. 

Queries :  Should  the  use  of  children,  if  permitted  at  all,  be  restricted 
to  research  which  seeks  to  cure  their  disease  or  to  diagnose  their  con- 
ditions, or  should  permission  be  extended  to  attempts  to  learn  more 
about  the  disease  from  which  they  are  suffering,  or  even  to  investiga- 
tions unrelated  to  their  individual  needs : 

Under  what  circumstances  can  parents  give  permission  for  the  par- 
ticipation of  their  children  in  research ;  when,  in  having  done  so,  could 
they  be  charged  with  "neglect"?  Should  children  be  used  in  experi- 
ments, as  in  the  Willowbrook  studies,  when  the  disease  for  w^hich  a 
remedy  was  being  sought  was  at  least  in  part  the  result  of  the  terrible 
conditions  under  which  society  had  condemned  them  to  live? 

(A  similar  question  can  be  raised  with  respect  to  the  Tuskegee 
Syphilis  Study.)  (3)  Lack  of  clarity  as  to  the  jurisdiction  of  insti- 
tutional review  committees. 


1052 

Queries :  When  does  an  experimental  procedure,  which  is  subject  to 
review,  be€ome  an  "established  and  accepted"  method  of  treatment? 
This  remains  an  unresolved  question,  particularly  since  it  has  been  so 
frequently  asserted  that  "the  therapy  of  disease  is,  and  always  will  be, 
an  experimental  aspect  of  medicine." 

(4)  Research  in  other  disciplines.  The  problems  posed  by  human 
research  are  not  restricted  to  medicine  but  extend  to  psychology, 
sociology,  law,  anthropology  and  other  disciplines. 

Queries :  What  about  the  limits  of  deception  experiments  and  secret 
observation  studies  so  frequently  employed  in  phychology  and  soci- 
ology ?  For  example,  the  guidelines  allow  that  for  tliese  purposes  con- 
sent can  be  obtained  "after  the  fact,"  b\it  this  provision  is  so  general 
in  scope  and  so  extensive  in  its  discretion  that  it  staggers 
the  imagination. 

With  this  one  sentence  fidelity  to  informed  consent  is  seriously 
undermined.  What  are  "the  circumstances  of  the  project"  which  could 
ever  permit  such  invasions  of  subjects'  lights  to  self-determination  and 
privacy?  Can  discretion  to  perform  such  experiments  ever  be  left 
solely  to  individual  investigators,  even  after  consultation  with  their 
peers  ? 

Review  committees  are  also  asked  to  "determine  that  the  rights  and 
welfare  of  the  subjects  are  adequately  protected."  What  rights  do  re- 
search subjects  have  ?  The  confusion  on  this  question,  in  part,  the  result 
of  the  traditional,  but  largely  unexamined,  prerogative  of  profes- 
sionals to  intervene  on  their  patients'  behalf  without  full  disclosure 
whenever  it  is  supposed  to  be  "in  their  patients  best  interests." 

Most  investigators  who  conduct  human  reseai-ch  liave  been  trained 
first  as  clinicians,  and  the  tremendous  authority  which  society  seems 
to  have  delegated  to  professionals  in  their  intei'action  with  pat'ents  is 
often  unwittingly  applied  in  research  settings. 

This  problem  has  not  received  the  attention  it  deserves;  indeed,  it 
has  Avider  ramifications,  for  my  inquiries  have  convinced  me  that  the 
overall  authority  which  professionals  have  been  permitted  to  exercise 
in  the  clinical  arena  requires  serious  leexamination.  In  all  professional 
schools  the  topic  of  "professional  responsibility"  has  not  been  ade- 
quately addressed  with  depth  and  conviction. 

^loreover,  it  has  been  insufficiently  recognized  that  the  decision  to 
conduct  research  is  not  solely  a  judgment  for  professionals  to  make 
but  represents  a  value  judgment  which  requires  the  "informed  con- 
sent" of  society.  And  much  too  little  attention  has  been  paid  to  the 
question  of  how,  and  by  what  procedures,  society  can  be  adequately  in- 
formed and  given  a  role  in  the  research  decisionmaking  process. 

I  have  raised  these  questions  not  only  to  point  out  to  you  the  com- 
plexity of  the  issues  which  require  careful  attention  but  also  to  raise 
doubts  about  the  oft  made  assertion  that  the  "ethics  of  human  experi- 
mentation are  best  safeguarded  by  the  presence  of  an  intelligent,  in- 
formed conscientious,  compassionate,  responsible  investigator." 

These  attributes  are  prerequisites  but  much  more  is  required.  Ironi- 
cally, it  seems  to  me,  that  just  such  an  investigator  would  be  the  one 
most  likely  to  demand  greater  guidance  before  embarking  with  his 
patients  on  the  currently  so  uncharted  research  voyage  into  the 
unknown. 


1053 

In  li^ht  of  these  considerations,  I  would  like  to  suggest  that  Con- 
gress give  serious  consideration  to  the  establishment  of  a  permanent 
body*  having  the  authority  to  regulate  at  least  all  federally 
supported  research  involving  human  subjects,  be  in  conducted  in  intra- 
mural or  extramural  settings,  or  sponsored  by  DHEW  or  other  gov- 
ernmental agencies,  such  as  the  Department  of  Defense.  It  could  be 
called  the  National  Human  Investigation  Board. 

The  Board  should  be  independent  of  DHEW,  for  I  do  not  believe 
that  the  agency  which  both  conducts  a  great  deal  of  research  itself  and 
supports  much  of  the  research  that  is  carried  on  elsewhere  is  in  a  posi- 
tion to  carry  out  dispassionately  the  functions  I  have  in  mind. 

The  major  responsibilities  of  this  Board  should  be  to  formulate  re- 
search policies,  including  detailed  provisions  for  the  administration  of 
the  research  enterprise  as  well  as  for  the  review  of  research  decisions 
and  their  consequences. 

In  the  time  allotted  to  me  I  can  only  very  briefly  highlight  the  struc- 
ture and  functions  of  this  Board.  The  members  of  the  Board  probably 
should  be  appointed  by  the  President,  and  its  members  should  come 
from  many  disciplines,  including  repersentatives  from  the  public  at 
large. 

Membership  should  not  be  restricted  solely  to  persons  from  the  pro- 
fessional and  scientific  community.  The  Board  must  have  regulatory 
authority;  it  should  formulate  detailed  policies  on  such  issues  as  sub- 
ject selection,  the  ambit  of  informed  consent,  the  definition  of  "re- 
search,'' the  application  of  risk-benefit  criteria,  etc. 

Moreover,  the  Board  should  promulgate  rules  and  procedures  for 
the  administration  and  review  of  the  human  research  process.  Hope- 
fully, once  adequate  policy-making  and  review  mechanisms  have  been 
established,  the  administration  of  research  practices  can  be  left  to  the 
immediate  participants — the  physican-investigators  and  patient- 
subjects — who  should  be  permitted  to  reach  their  own  accommodations 
with  as  little  interference  as  possible. 

Whatever  additional  controls  may  be  necessary  should  be  adminis- 
tered by  the  inviestigators'  peers  on  Institutional  Review  Committees; 
therefore,  these  committees  should  continue  to  exist  but  they  would  re- 
ceive much  firmer  guidance.  Indeed,  the  Institutional  Review  Commit- 
tees should  have  free  access  to  the  Board  for  any  advisory  opinions 
they  may  require. 

Finally,  and  again  all  too  briefly,  the  National  Human  Investigation 
Board  must  also  create  a  structure  for  the  review  of  research  prac- 
tices. Here  most  important  is  the  establishment  of  procedures  for  the 
l)ublication  of  the  important  decisions  rendered  at  the  local  and  na- 
tional level. 

This  would  radically  change  the  current  uninformed  and  secretive 
climate  which  pervades  research  decisionmaking.  At  present  decision- 
making remains  divorced  from  pertinent  prior  decisions  of  other  com- 
mittees or  from  scholarly  and  public  evaluation  and  criticism. 

"Published  cases"  as  Professor  Calabresi  has  suggested,  "would  soon 
become  the  subject  of  intensive  study  both  inside  and  outside  the 
medical  profession.  Analyses  in  learned  journals  by  lawyers,  doctors, 
and  historians  of  science  would  inevitably  follow  .  .  .  From  all  this,  a 
sense  of  what  society  at  large  deems  proper  in  medical  experiments 
might  well  arise. 


1054 

The  result  would  not  only  be  better  thought  out  decisions,  but  also 
a  more  complex  system  of  controls  which,  in  effect,  [would  take]  into 
account  much  broader  sources  of  information  as  to  societal  values  ..." 
Indeed  all  important  decisions  rendered  at  the  national  and  local  level 
should  be  published  and  preserved  in  easily  accessible  form.  This  would 
be  a  first  step  toward  the  case-by-case  development  of  policies  govern- 
ing human  experimentation.  I  regard  such  a  development,  analagous  to 
the  experience  of  the  common  law  as  the  best  hope  for  ultimately 
providing  workable  standards  for  the  regulation  of  the  human  ex- 
perimentation process. 

Essentially  my  proposals  are  designed  to  accomplish  three  important 
objectives  for  decisionmaking  in  human  research:  (1)  to  provide  an 
independent  regulatory  structure  as  well  as  orderly  and  effective  pro- 
cedures; (2)  to  give  a  significant  voice  to  representatives  of  society; 
and  (3)  to  subject  decisions  to  greater  public  and  scholarly  scrutiny. 

Lest  I  be  misunderstood,  I  do  not  make  these  recommendations  in 
order  to  stifle  research.  Medical  research  has  made  great  contributions 
to  the  alleviation  of  human  suffering  in  the  past  and  should  be  en- 
couraged to  do  so  in  the  future. 

Indeed,  I  believe  that  with  greater  public  participation  the  demand 
for  research  will  increase  in  intensity  because  society  has  always  had 
an  abiding  interest  in  benefiting  from  the  advances  of  medical  knowl- 
edge— disease  and  death  are  enemies  which  the  public  dreads  as  much, 
if  not  more,  than  do  the  professionals. 

But  at  the  same  time  I  value  respect  for  the  dignity  and  integrity  of 
man  even  more  than  the  advancement  of  science.  For  progress  is  an 
optional  goal  and  we  have  much  more  to  lose,  as  we  have  lost  already, 
from  the  erosion  of  the  moral  values  which  inevitably  follows  any 
unauthorized  invasion  of  man's  mind  and  body.  It  is  to  this  higher 
goal  that  my  recommendations  speak. 

Perhaps  it  is  true,  as  one  English  reviewer  of -my  book  on  Experi- 
mentation tcith  Human  Beings — Russell  Sage  Foundation,  1972 — 
noted,  that  the  moral  climate  for  ethical  experimentation  can  "be 
achieved  only  Avhen  larger  issues  such  as  war  and  racial  oppression  are 
accepted  as  matters  for  public  condemnation." 

But,  we  have  to  start  somewhere  and  where  is  a  better  place  to  begin 
than  in  the  arena  of  medicine  ?  Thus  I  present  my  recommendations  to 
you  in  the  hope  that  you  will  shape  them  into  rules  and  procedures 
which  will  respect  the  rights  of  subjects  and  the  claims  of  science  and 
which  are  formulated  with  greater  appreciation  of  the  "social  costs" 
we  are  willing  to  tolerate. 

Thank  you. 

Senator  Mondale.  Thank  you  very  much.  Dr.  Katz,  for  a  very  fine 
statement. 

Like  the  previous  witness,  I  gather  you  feel  that  the  evidence  is  so 
strong  that  we  should  go  beyond  a  study  commission  and  get  into  the 
field  of  action,  investigation,  and  establishment  of  rules  and  regula- 
tions. 

Dr.  Katz.  Yes.  Senator  Mondale,  I  am  familiar  with  the  bills  you 
have  introduced  and  the  various  statements  you  have  made  on  this 
subject.  I  believe  we  can -now  go  beyond  study  commissions  and  begin 
to  think  about  how  to  implement  some  of  the  recommendations  you 
have  made. 


1055 

Senator  Mondale.  What  are  the  objections  of  the  medical  profession 
to  your  proposal  ?  The  1968  attack  on  the  study  proposal  was  that  it 
would  inevitably  follow  that  something  such  as  you  are  talking  about 
would  be  established,  that  there  would  be  a  policeman  or  politician  in 
every  surgical  room,  and  the  political  demagogue  would  damage  medi- 
cal research  irreparably.  It  was  feared  that  our  great  American  medi- 
cal research  effort  would  be  adversely  affected  by  this  public  process. 

Dr.  Katz.  Objections  to  regulations  are  not  only  raised  by  the  bio- 
medical research  community.  Similar  objections  have  been  raised  by 
all  the  professions  whenever  regulations  are  being  considered. 

Professionals  don't  like  regulations.  They  would  like  to  do  things 
the  way  they  have  been  accustomed  to  doing  them.  They  are  afraid,  in 
part,  of  facing  up  to  troublesome  questions  about  research  subjects' 
rights  which  they  would  have  to  confront  once  a  regulatory  agency  is 
established. 

In  human  research  complex  and  troublesome  problems  require  reso- 
lution. Everybody  talks  about  informed  consent,  but  investigatoi'S 
don't  take  informed  consent  seriously.  If  a  researcher  would  have  to 
make  adequate  disclosures,  then,  with  respect  to  certain  experiments, 
he  would  have  to  entertain  the  possibility  of  a  very  frightening  con- 
frontation, which  the  researcher  would  first  have  to  face  up  to  in  his 
own  mind  and  then  with  his  patient. 

Finally,  for  the  past  few  years,  I  have  often  talked  to  the  medical 
profession  about  the  question,  **Why  do  you  not  begin  to  regulate 
yourself?  If  you  really  would  institute  meaningful  self-regulation, 
then  we  may  not  need  outside  regulation." 

But  again,  for  any  profession  to  regulate  itself  may  be  asking  for 
too  much  and  outside  pressure  may  have  to  be  applied. 

Senator  Mondale.  As  I  recall  when  we  had  hearings  five  years  ago 
and,  again,  two  years  ago,  that  was  one  of  the  answers  received.  That 
is,  that  while  too  little  had  been  done  in  the  past — to  be  sure — the  pro- 
fession was  now  energized  and  there  were  all  kinds  of  new  things 
under  way,  peer  review  groups  would  appear  everywhere  and  new 
standards  would  be  set.  Maybe  you  recall  that. 

Dr.  Katz.  Yes. 

Senator  Mondale.  Did  they  follow  through  on  that  promise  ? 

Dr.  Katz.  Not  to  my  know^ledge. 

Senator  Mondale.  One  of  the  interesting  things  about  this  particu- 
lar medical  dispute  is  that  normally  this  committee  finds  itself  at  war 
with  the  medical  profession  over  economics.  But  in  this  case  we  find 
ourselves  at  odds  with  the  academic  medical  community,  which  says, 
''Leave  us  alone.  Stay  off  our  campuses.  Send  us  the  money  but  don't 
come  in  and  see  how  we  do  our  experimenting." 

Is  there  some  hope  that  the  medical  teaching  profession  and  the 
research  profession  might  voluntarily  respond  better  than  they  have 
if  we  try  something  short  of  regulation  ? 

Dr.  Katz.  Perhaps  only  if  you  make  it  crystal  clear  that  they  must 
begin  to  do  something  about  these  problems,  and  surely  education  is 
one  avenue  to  pursue  more  seriously.  But  if  they  do  not  begin  to  regu- 
late themselves  more  effectively,  and  if  they  do  not  give  more  serious 
attention  to  these  problems,  then  you  must  tell  them  that  outside  regu- 
lation will  be  inevitable. 


1056 

Senator  Mondale.  You  were  a  member  of  the  Task  Force  investi- 
gating the  Tuskegee  experiment.  Were  your  initial  recommendations 
implemented  by  the  Secretary  of  HEW  ? 

Dr.  Katz.  I  learned  on  March  1  that  they  had  not  been  implemented. 

Senator  Mondale.  In  what  way  ? 

Dr.  Katz.  Mr.  Chairman,  I  do  not  want  to  talk  too  much  about  the 
Tuskegee  Syphilis  Study  because  Ave  are  still  in  the  process  of  writing 
our  final  report.  But  since  the  March  1  meeting  was  a  public  meeting, 
and  therefore  is  now  part  of  the  public  record,  I  can  say  that  our  panel 
sent  a  letter  to  the  Secretary  of  HEW  registering  our  indignation  that 
nothing  had  been  done,  and  we  asked  him  to  take  all  necessarv  steps  to 
provide  immediate  treatment  to  the  unfortunate  survivors  of  the  Tus- 
kegee Syphilis  Study. 

Senator  Mondale.  How  do  you  explain  this  pattern  of  inertia  ?  As  I 
recall  that  study  went  to  HEW  last  October,  together  with  recommen- 
dations, and  there  was  no  followup.  How  do  you  explain  this  peculiar 
reluctance  to  act  ? 

Dr.  Katz.  At  this  point  again,  Mr.  Chairman,  I  only  would  like  to 
state  what  w^e  were  told  at  that  meeting.  You  will  hear  more  about  my 
speculations  at  a  later  date,  after  March  31. 

We  were  told  that  the  Secretary  had  no  authority  to  provide  treat- 
ment, that  there  was  no  legal  authority  for  him  to  proceed. 

Senator  Mondale.  Hasn't  he  since  said  he  was  going  to  act  ? 

Dr.  Katz.  This  is  what  I  have  heard. 

Senator  Mondale.  If  he  has  no  authority,  how  is  he  going  to  act  ? 

Dr.  Katz.  I  don't  know. 

Senator  Mondale.  Where  would  you  locate  the  regulatory  body  that 
you  propose  to  be  established  ?  In  HEW,  or  elsewhere  ? 

Dr.  Katz.  It  would  be  best  if  it  were  a  separate  administrative 
agency,  outside  of  DHEW.  If  this  should  prove  too  difficult  a  proposal 
to  implement,  and  if  the  regulatory  body  has  to  be  retained  within 
DHEW,  then  the  persons  charged  with  regulating  research  ought  to 
be  given  much  greater  power  and  much  greater  authority  than  they 
presently  have. 

I  think  in  the  best  of  all  possible  worlds,  it  should  be  a  regulatory 
agency  which  is  completely  divorced  from  DHEW.  By  the  way,  I  shall 
make  more  detailed  proposals  with  respect  to  my  thoughts  on  the  func- 
tions of  such  a  regulatory  agency  sometime  next  month. 

Senator  Mondale.  Would  this  body  have  authority,  say,  in  Defense 
Department-funded  experimentation  ? 

Dr.  Katz.  I  should  hope  so. 

Senator  Mondale.  If  you  put  it  in  HP]W,  wouldn't  there  be  a  con- 
flict of  interest  ? 

Dr.  Katz.  Exactly.  This  is  why  I  would  very  much  prefer  that  it  be 
outside  of  HEW. 

Senator  Mondale.  This  is  the  problem  we  are  having  with  OEO's 
Legal  Services  program.  The  OEO  lawyers  have  all  been  suing  the 
Department  of  Justice  and  the  De]:)artment  of  HEW.  Some  of  their 
better  lawsuits  are  against  the  Government. 

Where  do  you  put  the  institution  that  its  lawyers  are  able  to  do  what 
their  profession  requires  of  them  ?  I  would  think  you  would  have  an 
identical  problem  here  in  the  medical  field. 


I 


1057 

Many  times  this  body  would  be  in  the  position  of  investigating  and 
enforcing  regulations  against  members  of  their  own  profession  and 
against  the  governmental  agencies. 

Dr.  Katz.  Exactly.  This  is  why  I  propose  that  it  be  outside  of 
DHEW. 

Senator  Mondale.  Where  would  it  get  its  money  ? 

Dr  Katz.  There  are  so  many  important  human  issues  involved  here 
that  I  hope  money  will  be  allocated  for  these  purposes. 

Senator  Mondale.  xJaybe  you  better  think  about  that.  We  found  in 
GEO,  in  Legal  Services  and  similar  programs,  that  every  time  you  try 
to  get  money,  they  try  to  hold  the  money  back  as  a  condition  for  ha^dng 
their  way.  Perhaps  wc  ought  to  develop  some  automatic  funding  set 
aside,  beyond  the  reach  of  anybody,  maybe  one-tenth  of  the  Public 
Health  Budget  would  have  to  go  to  this  body  under  a  legislative 
mandate. 

Dr.  Katz.  Senator  Mondale,  one  could  argue  that  to  create  meaning- 
ful ethical  standards  is  an  important  research  project  in  its  own  right, 
and  a  certain  percentage  of  the  research  money  that  is  being  given  to 
other  investigations  covild  be  allocated  for  these  purposes. 

Senator  Moxdale.  We  already  set  aside  1  percent  of  healthy  money 
for  evaluation.  Maybe  1  percent  for  this  would  make  sense.  I  wouldn't 
underestimate  the  funding  problem  at  all. 

I  gather  it  has  been  your  experience  that  the  most  questionable  ex- 
periments are  carried  out  on  primarily  the  poor  citizens  of  this  country. 

Dr.  Katz.  I  think  that  is  quite  correct. 

Senator  Mondale.  And  on  children  ? 

Dr.  Katz.  And  on  children  and  on  prisoners. 

Senator  Mondale.  Would  the  same  conclusion  be  true  of  children, 
that  they  tend  to  be  the  children  of  the  poor,  or  because  they  are  un- 
able to  defend  themselves  as  children  ? 

Dr.  Katz.  Yes.  A  great  many  such  experiments  have  been  conducted 
and  I  have  described  some  of  them  in  my  book,  in  the  chapter  on  insti- 
tutionalized children. 

Senator  Mondale.  Do  you  believe  that  HEW  has  been  successful  in 
enforcing  the  regulations  it  has  in  effect  for  the  conduct  of  experiments 
using  Federal  funds  ? 

Dr.  Katz.  I  believe  that  they  have  not  been  in  a  position  to  effectively 
enforce  the  regulations.  The  regulations  require  so  much  interpretation 
that,  if  you  want  to  take  them  seriously,  you  would  have  to  spend  con- 
siderable amounts  of  time  to  determine  first  what  these  terms  of  art 
mean. 

This  is  why  I  have  made  the  suggestion  that  we  need  procedures  for 
the  publications  of  all  important  research  decisions,  and  establish  for 
medicine  a  somewhat  similar  system  as  exists  in  law,  namely  the  case 
method  o^  decisionmaking.  Then  decisions  can  be  reviewed,  discussed, 
past  precedents  can  be  examined,  and  new  precedents  can  be  established. 
Tt  could  lead  to  the  establishment  of  what  I  call  a  medical  common  law 
with  respect  to  human  experimentation. 

Senator  Mondale.  Yesterday  I  understand  the  drug  industry  testi- 
fied there  is  no  alternative  to  testing  new  drugs,  initially,  on  prisoners. 
Do  you  agree  with  that?  Under  what  conditions  should  we  perform 
tests  on  prisoners  and  how  can  we  effectively  safegiuxrd  their  health? 

Dr.  Katz.  I  see  no  reason  why  other  alternatives  could  not  be 


1058 

devised.  After  all,  drug  testing  is  intended  to  benefit  all  of  us.  Why 
cannot  a  system  be  created  which  makes  it  possible  that  only  pro- 
portionate numbers  of  prisoners  be  used  and  that  a  proportionate 
number  of  people  from  the  population  at  large  be  used,  too,  for  these 
types  of  medical  experiments. 

Why  is  it  that  again  and  again  we  only  select  advantaged  people 
for  the  conduct  of  these  necessary  experiments  ? 

Senator  Mondale.  Counsel  tells  me  that  much  of  the  medical  ex- 
perimentation that  we  have  heard  about  has  taken  place  outside  of 
university  centers. 

The  record  shows  that  doctors  have  used  drugs  for  purposes  other 
than  for  which  they  were  intended,  and  used  certain  procedures  whicli 
are  experimental — merely  on  the  basis  of  their  own  judgment,  includ- 
ing the  use  of  experimental  medical  devices.  How  can  we  control  or 
govern  this  kind  of  problem  ? 

Dr.  Katz.  This  situation  creates  tremendous  problems,  as  you  are 
well  aware  of,  Senator  Mondale.  In  my  opening  statement  which  I 
submitted  to  you,  I  underlined  that  at  least  all  federally  supported 
research  ought  to  be  regulated  by  this  Board.  As  I  understand  the 
problem,  and  I  have  talked  about  it  with  my  colleagues  at  the  laAv 
school  who  teach  administrative  law,  difficult  Federal-State  problems 
would  have  to  be  resolved  before  research  which  is  not  supported  by 
the  Government  could  be  regulated. 

Though  they  do  not  think  that  it  is  an  insurmountable  problem,  it 
will  have  to  be  given  very  serious  and  careful  thought.  As  I  under- 
stand it  at  the  moment,  Congress  may  not  have  the  authority  to  regu- 
late research  which  is  not  Government- funded. 

But  may  I  add  one  additional  sentence.  Senator  Mondale.  I  would 
expect,  if  such  Board  were  to  draft  meaningful  regulations,  that  the 
rest  of  the  research  community,  and  even  the  entire  medical  com- 
munity would  gradually  adopt  these  rules  and  procedures. 

One  of  the  problems  is,  that  the  disregard  of  existing  regulations  is 
due  to  the  fact  that  they  are  so  difficult  to  understand  and,  therefore, 
so  difficult  to  implement. 

Senator  Mondale.  There  is  nothing  in  your  proposal  that  will  make 
them  anymore  acceptable. 

Dr.  Katz.  Hopefully,  one  of  the  functions  of  this  permanent  body 
will  be  to  draft  more  meaningful  regulations.  We  need  meaningful 
regulations. 

Senator  Mondale.  Can  you  refer  us  to  some  governmental  agency 
that  drafts  clear  regulations  ? 

Dr.  Katz.  Of  course,  this  will  be  a  real  problem.  But  I  see  no 
reason,  if  thoughtful  people  are  appointed  to  this  Board,  that  we 
cannot  have  better  regulations  than  we  have  now.  Much  will  depend 
on  the  persons  who  will  be  appointed  to  this  policy-making  Board. 

Senator  Mondale.  I  think  that  is  one  of  the  difficulties.  I  find  it 
hard  to  know  just  how  we  will  draft  this  guidance  without  making  it 
complicated.  But  that  is  the  question,  is  the  problem  so  serious  that 
we  have  to  come  face  to  face  with  it,  and  your  answer  is  yes. 

Dr.  Katz.  The  problem  i^  serious,  yes. 

Senator  Mondale.  We  have  to  deal  with  the  problem  of  clearer 
regulations  and  also  try  to  develop,  through  the  case  method,  a  body 
of  law  which  is  sufficiently  flexible  and  which  can  be  implemented  in 
principle. 


1059 

Dr.  Katz.  Exactly.  I  hope  this  will  be  one  of  the  proposals  that  will 
be  implemented,  because  I  expect  great  benefits  to  be  derived  from  its 
adoption. 

Senator  Mondale.  Thank  you  very  much. 

Our  next  witness  is  Dr.  Henry  K.  Beecher,  Professor  Emeritus. 
Harvard  Medical  School,  and  the  author  of  numerous  articles  and 
essays. 

STATEMENT  OF  HENRY  K.  BEECHER,  M.D.,  HARVARD  MEDICAL 

SCHOOL,  BOSTON,  MASS. 

Dr.  Beecher.  I  do  not  think  I  am  being  overly  optimistic  when  I 
say  that  significant  progress  has  followed  the  emotional  explosion  at 
the  Brook  Lodge  Conference,  March  22,  1965,  where  I  presented  some 
50  examples  of  what  I  believed  to  be  unethical  human  experimentation. 
The  substance  of  the  Brook  Lodge  Conference  was  published  in  1966 
in  the  New  England  Journal  of  Medicine,  Volume  274,  pp.  354—360. 

Some  of  you  will  recall  that  I  had  published  (January  31,  1959)  a 
report  to  the  Council  on  Drugs  of  the  American  Medical  Association 
with  the  title  "Experimentation  in  Man."  This  was  republished  as  a 
small  book  in  1959,  and  it  had  all  of  the  impact  of  a  soap  bubble  in  a 
high  wind. 

Certain  principles  were  laid  down  there  which  were  invoked  once 
more  in  the  stormy  paper  "Ethics  and  Clinical  Research,"  published 
in  1966  in  the  New  England  Journal  of  Medicine.  In  the  latter  case, 
the  publication  was  based  on  22  examples  (chosen  by  the  editors  froni 
the  50  presented) . 

This  had  consequences  more  extensive  than  I  could  have  imagined 
would  be  the  case.  This  paper  produced,  I  am  obliged  to  say,  a  great 
deal  of  indignation :  Two  medical  colleagues  called  a  press  conference 
at  Brook  Lodge  to  refute  my  study. 

They  were  given  an  opportunity  to  present  their  views.  I  was  not. 
The  conference  was  abruptly  terminated  after  the  two  colleagues  had 
made  their  statements.  The  press  enjoys  a  disagreement  among  doctors, 
and  made  the  most  of  it.  Furthermore,  my  publication  was  regarded 
by  a  good  many  able  colleagues  as  not  only  a  breach  of  medical  custom, 
but  it  had  other  unhappy  consequences. 

Many  felt  threatened  by  this  report.  Evidently,  they  feared  curtail- 
ment of  their  present  or  future  research  activities.  Some,  it  must  be 
admitted,  certainly  disliked  having  attention  called  to  their  patently 
unethical  activities  in  the  past,  even  though  citation  was  made 
anonymously. 

The  last  two  comments  contain  their  own  commentary  on  the  situa- 
tion. At  about  the  same  time,  you  will  recall,  Dr.  Southam  of  the 
Memorial  Hospital  in  New  York  and  a  colleague  were  much  criticized 
for  having  injected  live  cancer  cells  into  sick  elderly  people  in  a  Brook- 
lyn hospital.  The  subjects  did  not  know  that  live  cancer  cells  were 
injected. 

I  have  briefly  reviewed  this  unhappy  bit  of  history  to  serve  as  a 
background  for  the  changes  which  have  occurred  in  the  last  8  or 
9  years.  I  am  glad  to  report  that  once  again,  almost  everybody 
speaks  to  me,  and  I  believe  that  unbiased  individuals  would  generally 
now  agree  that  the  1966  paper  had  served  a  useful,  not  destructive, 


1060 

purpose.  It  had  long  been  my  view  that  ethical  errors  in  research  were 
owing  to  carelessness  or  thoughtlessness  or  ignorance  and  not  to  a 
vicious  disregard  for  the  subject's  welfare.  I  can  offer  you  some  con- 
crete evidence  that  this  is  the  case. 

In  1966,  the  National  Institutes  of  Health  reported  to  me  through 
Dr.  Confrey  that  approximately  7  percent  of  the  applications  for 
grants  received  contained  unethical  aspects.  Six  months  after  the  pub- 
lication of  the  1966  paper,  that  percentage  had  fallen  down  to  a  third 
of  what  it  had  been :  2.4  to  2.1  percent,  and  this  low  level  held  for  the 
subsequent  years  when  I  followed  this  material. 

These  data  support  my  strongly  held  belief  that  merely  calling 
attention  to  the  possibilities  for  error  in  the  field  of  experimentation 
would  result  in  a  much  improved  situation.  The  data  just  referred  to 
support  that  conclusion. 

The  point  I  wish  to  make  is  that  the  situation  regarding  ethics  and 
clinical  research  has  improved. 

I  am  not  trying  to  suggest  that  all  problems  have  been  solved;  we 
are  still  a  considerable  distance  from  that  goal.  It  is  important  that  we 
face  up  to  situations  in  this  field  of  experimentation  in  man  and,  for 
example,  simply  admit  our  inability  to  achieve  "informed  consent"  in 
most  cases.  A  great  deal  of  talk  and  dozens  of  so-called  codes  of  experi- 
mentation have  emphasized  the  importance  of  getting  "informed 
consent." 

In  all  honesty,  we  must  agree  that  "informed  consent"  is  a  goal 
toward  which  we  must  strive,  a  goal  practically  never  attained  in  even 
a  moderately  complex  situation.  We  can  and  must  continue  to  struggle 
toward  this  goal,  and  there  are  some  things  one  can  say  about  it  of  a 
helpful  nature :  The  struggle  for  "informed  consent"  means  that  the 
intended  subject  will,  at  least,  be  aware  of  the  fact  that  he  is  to  partici- 
pate in  an  experiment.  This  contrasts  sharply  with  situations  described 
in  the  1966  paper  of  other  years,  where  many  individuals,  even  some 
hundreds,  never  knew  they  were  to  participate  in  an  experiment,  with 
consequent  serious  damage  to  their  healtli  and,  in  some  cases,  loss  of 
life. 

Edmond  Cahn  has  had  some  penetrating  comments  to  make  on  this : 

One  of  the  ma.ior  malpractices  of  our  era  consists  in  the  "eng^ineering  of  con- 
sent." Sometimes  this  is  effected  simply  by  exploiting  the  condition  of  necessitous 
men,  as  in  certain  Indian  states  where  thousands  of  consents  to  sexual  steriliza- 
tion have  been  purchased  by  offering  a  trivial  county  to  the  members  of  a  desti- 
tute caste. 

Then  again,  consent  may  be  "engineered"  by  the  kind  of  psychologist  who  takes 
it  for  granted  that  his  assistants  and  students  will  submit  to  experiments  and 
implies  a  threat  to  advancement  if  they  raise  objections.  Or  the  total  community 
may  "engineer"  a  consent,  as  when  the  president,  the  generals,  and  the  news- 
papers call  \yith  loud  fanfare  for  a  heroic  crew  of  astronautical  volunteers  to 
attempt  some  ultrahazardous  exploit. 

It  is  worth  considering  that  the  destitute  Indians  who  accept  payment  for 
sterilization  can  at  least  know  what  they  are  consenting  to ;  the  psychological 
and  astronautical  subjects  cannot.  Moreover,  though  the  astronauts  are  fairly 
certain  of  winning  some  species  of  glory,  the  lady  who  submits  to  hypnosis  in  the 
interest  of  science  is  certain  of  scarcely  anything.  Fortunately,  there  is  evidence 
that  responsible  psychologists  are  becoming  aware  of  the  problem  and  are  seek- 
ing to  cope  with  it.  Even  a  free  consent  must  have  moral  limits  in  a  society  that 
honors  human  dignity  and,  honoring  it,  puts  a  ceiling-price  on  truth. ^ 


^Cahn,  E.  Limits  for  experimentation.  Excerpt  from  "The  Lawyer  as  Scientist  and 
Scoundrel :  Reflections  on  Francis  Bacon's  Quadricentennial,"  New  York  University  Law 
Review  36,  1-12.  1961. 


1061 

Lord  Henley,  as  long  ago  as  1762,  clearly  saw  the  problem : 

Necessitous  men  are  not,  truly  speaking,  free  men,  but,  to  answer  a  present 
exigency,  will  submit  to  any  terms  that  the  crafty  may  impose  on  them.^ 

Professor  Freund  has  suggested  that  a  more  realistic  approach  to  the 
"consent"  problem  is  to  obtain  "informed  participation."  This  comes 
much  nearer  to  what  can  be  achieved  in  the  factual  situation. 

Thus,  facing  up  to  the  troublesome  issues  involved  can  have  positive 
results.  It  is  clear  that  progress  of  a  positive  nature  has  been  made  in 
the  last  8  years.  But  the  situation  is  not  as  satisfactory  as  one 
would  like.  Anyone  who  reads  the  newspapers  can  verify  this.  For 
example,  there  is  Dr.  Joseph  Goldzieher's  "experimental  pregnancy" 
wherein  the  ethical  complexities  of  experimentation  with  oral  contra- 
ceptives were  evident. 

According  to  Dr.  Goldzieher,  the  purpose  of  his  experiment  was  to 
find  out  whether  some  of  the  reported  side  effects  of  "the  pill"  were 
physiological  or  psychological.  In  a  double-blind  experiment,  he  found 
that  76  w^omen  received  placebos,  that  is,  dummy  pills,  while  another 
group  received  various  hormone  contraceptives. 

The  subjects  were  Mexican- American  women  who  had  gone  to  the 
San  Antonio  Clinic  for  contraceptives.  All  had  gone  there,  not  to  assist 
in  research,  but  to  prevent  further  pregnancies.  They  were  not  in- 
formed that  they  were  receiving  placebos,  nor  were  they  told  that  they 
were  participating  in  research.  They  were  instructed  to  use  a  vaginal 
cream  since  the  pill  they  were  to  get  might  not  be  completely  effective. 
Unfortunately,  10  of  the  women  on  placebos  rather  promptly  became 
pregnant. 

What  the  total  number  of  pregnancies  may  now  be  is  not  known  to 
me.  This  study  evoked  a  considerable  degree  of  unfavorable  criticism. 
For  example.  Dr.  Christopher  Tietz  of  the  Population  Council  was 
quoted  as  saying : 

No  responsible  investigator  would  take  it  upon  himself  to  expose  women  seek- 
ing protection  to  the  risk  of  pregnancy  by  ostensibly  giving  them  .  .  .  mere 
glucose,  or  at  best,  some  vitamins.^ 

Senator  Mondale.  Was  this  in  1966  ? 

Dr.  Beecher.  It  was  in  1972. 

Senator  Moxdale.  So  it  is  very  recent. 

Dr.  Beecher.  It  is  current. 

Senator  Mondale.  And  it  took  place  in  San  Antonio  with  Mexican- 
American  women? 

Dr.  Beecher.  That  is  right. 

Senator  Mondale.  These  women  came  to  the  hospital  expecting  to 
receive  help  in  contraception. 

Dr.  Beecher.  That  is  right. 

Senator  Moxdale.  Without  their  knowledge,  some  of  them  were 
given  medication  which  in  no  way  served  as  a  contraceptive  ? 

Dr.  Beecher.  That  is  right. 

Senator  Mondale.  They  were  not  told  this  ? 

Dr.  Beecher.  No. 

Senator  Mondale.  And  as  a  result,  10  of  them  became  pregnant? 

"Henley,  Lord.  Vernon  v.  Bethell,  28  Eng.  Ren.  838,  839  (ch.  1762). 

^Veatch,  R.  M.  "Experimental  Prej?nancv,"  The  Hastings  Center  Report.  Institute  of 
Society,  Ethics,  and  the  Life  Sciences,  pp.  2-3.  June  1971. 


93-999  O  -  73  -  pt.  3  —  1) 


1062 

Dr.  Beecher.  Probably  a  good  many  more  by  this  time.  This  in- 
formation is  some  months  old. 

Senator  Mondale.  The  idea  was  the  physicians  wanted  to  find  out 
the  side  effects  of  the  pill,  whether  physiological  or  psychological. 
What  right  does  a  doctor  have  to  do  that  ? 

Dr.  Beecher.  N^one  whatever. 

Senator  Mondale.  Is  there  any  law  against  it  ? 

Dr.  Beecher.  Well,  there  is  a  law  against  deceit.  These  ladies  were 
deceived.  It  is  a  curious  commentary  on  the  medical  world. 

Senator  Mondale.  The  only  remedy  would  probably  be  a  mal- 
practice suit,  wouldn't  it? 

Dr.  Beecher.  I  am  not  a  lawyer,  sir. 

Senator  Mondale.  Shouldn  t  Dr.  Goldzieher  pay  for  the  cost  of 
raising  those  children,  and  see  whether  it  is  physiological  or  psycho- 
logical with  him  ? 

Dr.  Beecher.  Yes,  if  they  die.  If  a  mother  dies  in  childbiith,  who 
is  responsible? 

Senator  Mondale.  Who  will  pay  for  that  ? 

Dr.  Beecher.  That  is  a  very  good  question. 

Senator  Mondale.  Once  again  we  have  the  phenomenon  of  poor 
minority  people  being  practiced  on.  What  if  he  did  that  in  a  rich, 
upper  middle-class  white  area  in  New  York  ? 

Dr.  Beecher.  That  is  impossible  in  my  view. 

Senator  Mondale.  Well,  they  wouldn't  know  about  it. 

Dr.  Beecher.  They  wouldn't  participate. 

Senator  Mondale.  They  might  if  they  don't  know  about  it. 

Dr.  Beecher.  But  I  think  that  is  deceit,  too. 

Senator  Mondale.  This  is  now  a  public  fact  ? 

Dr.  Beecher.  Yes. 

Senator  Mondale.  What  has  been  the  reaction  of  the  medical 
profession  ? 

Dr.  Beecher.  It  has  been  dreadful.  The  local  medical  society,  I 
am  informed,  in  San  Antonio,  issued  a  great  vote  of  confidence  in  the 
doctor,  and  defined  this  experiment  in  very  glowing  terms  as  a  fine, 
upstanding  job.  That  is  hearsay. 

Senator  Mondale.  Does  the  medical  society  have  professional  dis- 
ciplinary bodies? 

Dr.  Beecher.  Yes. 

Senator  Mondale.  Have  they  disciplined  the  doctor  ? 

Dr.  Beecher.  No.  They  approved  him. 

Senator  Mondale.  They  what? 

Dr.  Beecher.  They  said  he  had  done  a  fine  job.  That  is  hearsay, 
but  I  think  it  is  accurate.  I  think  this  illustrates  how  far  apart  some 
attitudes  are. 

Senator  Mondale.  Who  paid  for  this  so-called  research  ? 

Dr.  Beecher.  Syntex  was  one  I  understand,  I  am  told. 

Senator  Mondale.  A  drug  company  ? 

Dr.  Beecher.  Yes.  And  I  think  HEW  had  something  to  do  with  it. 
I  am  not  positive  on  that. 

Senator  Mondale.  I  will  ask  the  staff  to  submit  for  the  record,  if 
we  ran  find  out,  who  paid  for  this.  They  should  write  to  the  Medical 
Society  in  San  Antonio  and  find  out  what  happened,  and  maybe 
write  a  couple  of  mothers  and  ask  them  hoAv  they  liked  it. 


1063 

Dr.  Beecher.  I  would  like  to  see  a  statement  from  the  San  Antonio 
Medical  Society.  IVliat  I  mentioned  just  now  is  hearsay,  but  I  have 
reason  to  believe  it  is  accurate.  It  would  be  well  to  request  a  statement. 

Senator  Moxdale.  Was  there  any  federal  money  in  this  ? 

Dr.  Beecher.  I  have  heard  there  was,  but,  again,  that  can  be 
checked.  I  have  heard  there  was  some  HEW  money  involved. 

Senator  Mondale.  We  will  write  and  see,  to  find  out  for  the  record. 

Please  proceed. 

Dr.  Beecher.  If  one  of  these  women  died  in  childbirth,  who  could 
be  held  responsible?  Dr.  Goldzieher?  Goldzieher's  experiment  raises 
many  questions  concerning  the  present  levels  of  control  over  experi- 
mental procedure.  I  have  already  mentioned  the  difficulties  of  getting 
^'informed  consent."  What  was  the  advantage  in  not  telling  the  patients 
that  they  Avere  to  be  experimental  subjects?  Quite  obviously,  it  was 
likely  that  many  would  have  refused  to  participate.  Need  more  be 
said? 

This  is  a  commentary  on  some  present  attitudes.  In  this  context,  it 
can  be  said  (so,  I  am  informed)  that  the  local  San  Antonio  Medical 
Society  made  a  statement  strongly  supporting  Dr.  Goldzieher.  As  Dr. 
Robert  Veatch  has  pounted  out,  responsibility  for  ethically  acceptable 
research  involves  the  financial  support,  the  institution  and  the  investi- 
gator. Moreover,  there  is  a  serious  question  in  the  minds  of  some,  and 
no  question  at  all  as  far  as  I  am  concerned,  as  to  whether  publishers 
should  accept  research  where  consent  procedures  are  not  clearly 
stated. 

Among  the  scores  of  ethical  questions  raised  by  the  Goldzieher 
study,  for  example,  are  the  investigators  and  the  Syntex  financial  sup- 
porters of  the  study  prepared  to  finance  the  products  (the  children) 
of  their  experiment?  It  seems  to  me  that  the  subjects  can  make  it  a 
legitimate  claim  for  full  support  for  the  children  produced. 

Another  serious  question  raised  by  this  study  is :  Why  were  Mexican- 
American  financially  poor  individuals  dominant  in  the  group  under 
investigation ?  Would  the  investigators'  wives  have  participated?  Why 
are  people  too  poor  to  pay  for  medical  care  utilized  in  this  way? 
These  academic  questions,  of  course,  have  obvious  answers.  Trust  is  a 
matter  for  earnest  concern. 

As  science  becomes  more  and  more  significant  in  the  modern  world, 
it  is  absolutely  essential  that  this  be  a  trusted  activity.  Margaret  Mead 
has  had  a  significant  statement  to  make  in  this  area : 

The  image  of  the  scientist  as  someone  who  is  trustworthy  and  humane  is  im- 
paired every  time  that  there  are  accounts  of  research  which  have  disregarded  basic 
human  rights  of  consent,  as  in  revelations  about  medical  experiments  on  uncon- 
senting  patients,  or  scientists  using  lying,  deceit,  disguises  and  spying  in  the 
collection  of  data,  or  misquoting  or  suppressing  evidence  in  the  discussion  of 
public  policy  .  .  .  Trust  in  the  responsible  use  of  power  is  essential  for  an  ordered 
society.  Trust  in  the  responsible  use  of  knowledge,  which  increasingly  gives 
overweaning  power,  is  crucial  today.* 

Let  us  consider  another  example :  It  is  most  unusual  for  normal 
healthy  vouns:  males  to  allow  their  testicles  to  be  harmed  to  be  injected 
and  incised,  but  this  was  done  in  prison  work,^  supported  in  part  by 

*  Mead,  >r.  Ethical  aspects  of  exr^rimentation  on  human  subiects  :  From  the  standpoint 
of  anthropology.  Conference  on  ETHICAL  ASPECTS  OF  EXPERIMENTATION  ON 
HUMAN  SUBJECTS,  American  Academy  of  Arts  and  Sciences,  Boston,  Mass..  Nov.  3-4. 
1967. 

5  Heller.  C.  G..  and  Clermont.  Y.  Kinetics  of  the  germinal  epithelium  in  man.  Recent 
Progr.  Hormone  Res.,  20.  545-575,  1964. 


I 


1064 

the  National  Institutes  of  Health  of  the  United  States  Public  Health 
Service. 

The  purpose  was  to  study  the  spermatogenic  process  in  man.  The 
subjects  were  inmates  of  a  state  penitentiary;  their  ages  varied  from 
20  to  42  years.  Bilateral  testicular  biopsies  were  made  under  local 
anesthesia.  The  scrotal  skin  and  tunica  were  incised  "and  the  testicular 
tissue  was  separated  from  the  tunica  by  lateral  undercuts  .  .  .  Due  to 
internal  pressure,  the  underlying  seminiferous  tubules  protruded  above 
the  tunica  and  were  severed  by  a  stroke  of  a  razor  blade.'' 

In  one  phase  of  the  study,  radioactive  thymidine-H^  was  injected 
into  the  testicles  and  the  sites  marked  with  a  black  thread  "so  that  the 
exact  area  could  be  relocated  for  subsequent  biopsies.'*  Eight  pre- 
viously vasectomized  inmates  volunteered  for  this  procedure. 

The  use  or  nonuse  of  prisoners  as  human  subjects  for  experimenta- 
tion can  be  debated.  The  ice  is  thin.  One  can  only  wonder  what  the 
coercive  force  was  on  the  prisoners.  Threats?  The  use  of  men  for  the 
procedures  stated  indicates  that  some  powerful  factors  must  have  been 
employed. 

At  the  Dartmouth  conference  on  "The  Great  Issues  of  Conscience 
in  Modern  Medicine"  of  I960,®  Warren  Weaver  described  statistical 
morality  as  derived  from  "the  prejudice  against  even  permitting  any 
one  known  specific  individual  to  sacrifice  his  life  for  the  common  good," 
and  yet  "we  have  to,  in  a  great  many  circumstances,  submit  a  lot  of 
individuals  to  a  partial  risk"  with  the  result  that  even  though  "the 
risk  is  only  one  in  a  million,  when  a  million  are  involved,  one  man  will 
be  dead  with  our  acquiescence  *  *  *  It  is  a  comfort  to  our  conscience 
that  we  don't  know  where  it  occurred  or  when  it  occurred.  But  that 
individual  is  just  as  dead  as  though  we  knew  all  about  it." 

In  such  deep  waters  we  strive  for  balance,  but  sometimes  emerge 
with  little  more  than  questions  and  tangled  arguments. 

For  example,  in  discussing  new  and  uncertain  risk  against  probable 
benefit.  Lord  Adrian  spoke  of  the  increase  in  Britain  of  mass  radiog- 
raphy of  the  chest.^  Four  and  a  half  million  examinations  were  made 
in  one  year  (1957). 

It  has  been  calculated  that  while  the  effects  of  the  radiation  on  bone 
marrow  might  possibly  have  caused  as  many  as  20  cases  of  leukemia 
in  that  year,  nevertheless  the  examinations  revealed  18,000  cases  of 
pulmonary  tuberculosis  needing  supervision,  as  well  as  thousands  of 
other  abnormalities. 

Although  20  deaths  from  luekemia  were  only  a  remote  possibility, 
Lord  Adrian  asks :  If  they  were  a  certainty,  would  they  have  been  too 
high  a  price  to  pay  for  the  early  detection  of  tuberculosis  in  18,000 
people  ?  The  problems  are  indeed  complex. 

In  the  area  under  discussion,  experimentation  in  man,  some  progress 
has  been  made  beyond  Eeston's  1965  statement :  ^ 

If  there  has  been  a  decline  of  decency  in  the  modern  world  and  a  revolt  against 
law  and  fair  dealing,  it  is  precisely  because  of  the  decline  in  the  belief  in  each 
man  as  something  precious. 

•Wenver,  W.  Comment  on  the  problem  of  statistical  morality.  The  Dartmouth  Convo- 
cation of  Great  Issues  of  Conscience  in  Modern  Medicine,  Sept.  8,  9,  10,  1960.  Dartmouth 
Alumni  Magazine  (Supplement),  November  19(50,  d.  4. 

7  Adrifin.  E.  D.  Priorities  in  medical  responsibility  (Jephcott  lecture),  Proc.  Roy.  Soc. 
Med.,  56,  523-528,  1963. 

»  Rpston,  J.  "Washington  :  The  Capital  and  the  Easter  Story,"  New  York  Times,  Apr.  18, 
1965. 


I 


1065 

Sometimes  it  is  argued  that  the  investigator's  primary  concern  is  the 
most  good  for  the  most  people.  This  is  refuted  by  Miranda  v.  State  of 
Arizona: 

It  is  not  admissible  to  do  a  great  right  by  doing  a  little  wrong.  ...  It  is  not 
sufficient  to  do  justice  by  obtaining  a  proper  result  by  irregular  or  improper 
means." 

In  closing,  I  would  like  to  quote  Rainer  Maria  Rilkke :  "That  we 
must  seek  to  do  the  difficult  is  a  certainty  that  shall  never  leave  us." 

Senator  Mondale.  Thank  you  very  much,  Dr.  Beecher,  for  your 
excellent  presentation. 

Today  we  have  heard  some  prominent  authors  and  scholars  suggest- 
ing that  we  should  go  beyond  a  study  and  set  up  some  sort  of  regula- 
tory, or  rule-making,  or  investigating  committee  or  commission.  Where 
do  you  stand  on  that  ? 

Dr.  Beecher.  I  think  it  would  be  a  mistake  to  conclude  that  no  prog- 
ress is  being  made.  I  think  very  important  progress  is  being  made. 
I  think  those  figures  I  mentioned,  7  percent  oi  unethical  cases  coming 
into  HEW  in  June  1966,  and  six  months  later  it  had  fallen  to  a  third 
of  that,  and  it  has  stayed  at  a  low  level.  I  think  simply  calling  atten- 
tion to  the  possibilities  for  error  can  go  a  great  distance  in  improving 
this  situation. 

Senator  Mondale.  And  yet  we  have  this  apparently  disgraceful  pro- 
gram currently  underway  in  San  Antonio. 

Dr.  Beecher.  We  haven't  solved  all  the  problems,  but  I  think  prog- 
ress is  being  made.  I  am  a  little  afraid  of  legalistics  here.  I  think  it  is 
too  soon  to  crystallize  out  these  things  in  terms  of  law. 

Senator  Mondale.  I  think  that  is  a  central  question — what  kind  of 
institution  would  you  set  up,  who  would  be  on  the  commission,  what 
kind  of  authority  would  it  have,  and  how  would  it  operate  with  respect 
to  experimentation,  medical  research  and  medical  practice  today? 
Would  its  advantages  exceed  its  disadvantages  ? 

Judging  by  the  philosophy  which  you  have  expressed  in  the  examples 
you  gave,  I  gather  you  come  down  strongly  on  the  side  of  protecting 
against  this  kind  of  experimentation  rather  than  what  might  be  argued 
in  its  defense  ? 

Dr.  Beecher.  I  think  it  is  a  matter  of  education.  I  think  most  medi- 
cal journals  are  now  refusing  to  publish  unethically  obtained  data. 
These  may  seem  like  simple  and  rather  naive  approaches  to  this  ter- 
ribly important  problem,  but  it  is  one  that  can  be  carried  out  with  other 
and  better  solutions  if  they  can  be  found. 

I  think  many  editors  would  not  have  refused  to  publish  unethical 
material  a  few  years  ago.  Now  it  happens  all  the  time.  Progress  is  being 
made.  We  have  a  long  way  to  go. 

Senator  Mondale.  You  are  a  little  reluctant  to  support  a  regulatory 
commission  at  this  time  ? 

Dr.  Beecher.  No  ;  I  am  strongly  for  the  Commission.  I  think  we  are 
all  learning:  things  about  human  experimentation.  I  mentioned  the  com- 
plexity. The  assumption  that  we  will  get  this  by  legislation  will  not 
do  it  at  all. 

Senator  Mondale.  We  have  seen  the  problem  in  the  FDA,  where  they 
have  had  many  difficulties.  I  am  concerned  about  what  the  remedy  is. 

»  Miranda  v.  State  of  Arizona,  384  U.S.  436,  447  (1966). 


I 


1066 

Maybe  you  can  think  about  that  a  little  bit  and  send  the  committee  any 
further  suggestions  you  might  have. 

NDr.  Beecher.  I  don't  think  this  problem  can  be  solved  short  of  a  mas- 
sive educational  effort. 

Senator  Mondale.  I  can  see  things  we  can  do.  For  example,  condi- 
tioning aid  to  institutions  of  medical  learning  to  require  adequate 
courses  in  ethics  and  in  the  social  implications  of  medicine. 

I  am  sure  there  would  be  resistance  even  to  that.  Certainly  the  study 
commission  proposed  by  us  in  the  last  three  Congresses  does  not  carry 
with  it,  I  think,  grave  risks  to  medical  research.  I  think  it  carries  great 
possibilities. 

The  great  question  is  whether  you  go  beyond  this  educational  process 
into  the  regulatory  function. 

Dr.  Beecher.  I  think  it  is  a  little  too  soon  for  this  to  be  frozen  into 
law.  There  are  certain  aspects,  of  course,  which  can  be. 

Senator  Mondajle.  And  yet  we  have  these  current  examples  that  seem 
outrageous.  Maybe  what  we  ought  to  do  is  develop  a  system  of  remedies. 
The  doctor  who  tricked  the  women  into  pregnancy,  maybe  ought  to  pay 
the  cost  of  educating  and  caring  for  these  children. 

Dr.  Beecher.  And  if  these  women  die  in  childbirth,  is  he  responsible  ? 

Senator  Mondale.  At  least  there  ought  to  be  some  kind  of  remedy 
for  the  consequences  of  this. 

Dr.  Beecher.  Yet  you  find  his  own  peei*s  saying  what  a  fine  job  he 
did. 

Senator  Mondale.  That  is  after  several  years  of  "education."  That 
is  why  I  wonder  whether  the  educational  principle  is  going  to  be 
sufficient. 

Dr.  Beecher.  I  would  not  consider  San  Antonio  to  be  an  adequate 
example.  Strong  efforts  to  educate  the  medical  and  scientific  public  do 
not  conflict  with  or  rule  out  other  approaches  for  improvement. 

INIy  point  was  that  progress  has  been  made  but  we  have  a  very  long 
wav  to  go. 

Senator  Mondale.  I  come  from  an  extraordinarily  ethical  profes- 
sion— law.  We  have  had  such  courses  for  years.  The  first  thing  you 
learn  in  an  ethics  course  is  you  can't  do  it.  If  you  have  that  answer 
firmly  in  mind  you  get  an  "A." 

This  has  been  going  on  for  over  a  hundred  years.  And  once  in  awhile, 
even  today,  lawyers  are  not  ethical. 

Dr.  Beecher.  You  always  agree  that  nothing  should  ever  be  done 
for  the  first  time,  don't  you  ? 

Senator  Mondale.  That  is  right. 

"Well,  this  is  a  tough  question.  I  think  the  examples  we  have  seen, 
the  syphilis  example,  this  example  in  San  Antonio,  and  others  like 
them,  are  utterly  outrageous,  immoral,  and  an  insult  to  the  human 
spirit. 

Now  the  question  is  whether  we  ought  to  follow  it  up  with  some  kind 
of  regulatory  move.  I  think  the  fact  that  it  is  troubling  you,  one  of 
the  great  leaders  in  the  field,  should  give  us  some  concern,  too. 

Dr.  Beecher.  I  am  Chairman  of  the  Standing  Committee  on  Ethics 
at  Harvard.  One  of  the  most  difficult  problems  that  we  have  right  now 
is  the  so-called  psychosurgery.  Psychosurgery  is  a  very  bad  term.  It 
covers  up  a  lot  of  very  bad  things,  I  think. 


1067 

Senator  Mondale.  The  other  thing  about  it  is  that  the  medical  pro- 
fession is  profoundly  suspicious  of  the  public  sector.  I  remember  a 
couple  of  years  ago  we  had  hearings  on  sudden  infant  death,  which, 
as  we  were  told^  is  the  largest  killer  of  infants. 

I  think  a  representative  from  NIH  said  we  shouldn't  eay  anything 
about  it  because  it  will  get  people  all  upset.  Why  this  reluctance  to 
discuss  these  things? 

Dr.  Beecher.  I  wasn't  reluctant. 

Senator  Mondale.  Not  on  your  part,  no. 

Dr.  Beecher.  There  may  be  a  reluctance  to  discuss  on  the  part  of 
my  colleagues.  But,  as  I  say,  they  all  now  speak  to  me  once  in  awhile. 

Senator  Mondale.  Thank  you  very  much,  sir. 

Senator  Kennedy.  Our  final  witness  is  Dr.  William  Barclay,  rep- 
resenting the  American  Medical  Association.  He  is  Assistant  Execu- 
tive Vice  President. 

STATEMENT  OF  WILLIAM  R.  BARCLAY,  M.D.,  ASSISTANT  EXECU- 
TIVE VICE  PRESIDENT,  AMERICAN  MEDICAL  ASSOCIATION, 
ACCOMPANIED  BY  EDWIN  J.  HOLMAN,  STAFF,  LEGAL  DEPART- 
MENT, AMERICAN  MEDICAL  ASSOCIATION 

Dr.  Barclay.  Mr.  Chairman,  I  am  Dr.  William  R.  Barclay,  Assist- 
ant Executive  Vice  President  of  the  American  Medical  Association. 
With  me  is  Mr.  Edwin  J.  Holman,  of  the  Association's  legal  depart- 
ment. We  are  pleased  to  appear  before  you  today  to  present  the  As- 
sociation's views  regarding  the  scientific,  moral,  and  ethical  considera- 
tions of  medical  experimentation. 

Before  going  to  the  AMA  I  was  a  Professor  of  Medicine  at  the  Uni- 
versity of  Chicago  Medical  School  and  I  have  personally  conducted 
a  number  of  clinical  trials. 

Also,  let  me  say  in  connection  with  the  subject  before  this  commit- 
tee, that  I  currently  serve  as  Chairman  of  the  Veterans'  Administra- 
tion Policy  Committee  which  reviews  clinical  trials  of  antibiotics  con- 
ducted by  the  VA.  We  are  particularly  pleased  by  this  committee's  in- 
terest in  the  manifold  issues  surrounding  human  experimentation. 

Modem  technological  advances  have  made  us  increasingly  aware  of 
the  potential  of  science,  particularly  in  the  area  of  biomedicine. 

Let  me  emphasize,  however,  that  the  American  Medical  Association 
has  a  long  history  of  active  concern  over  how  this  potential  can  be 
realized  without  violating  human  ethical  and  moral  values. 

This  concern  w^as  expressed  formally  in  1947  when  the  Association's 
House  of  Delegates  enunciated  ethical  standards  for  n^.edical  research 
with  human  subjects.  The  Association  proceeded  thereafter  to  adopt 
internationally  acknowledged  standards  when  it  endorsed  the  1964 
Declaration  of  Helsinki,  the  World  Medical  Association's  Guidelines 
for  Clinical  Investigation. 

In  1966  the  AMA  House  of  Delegates  augmented  these  guidelines 
when  it  adopted  ethical  guidelines  for  clinical  investigation,  a  copy  of 
Avhich  is  submitted  for  the  record.  We  are  gratified  to  find  that  you 
share  our  commitment  to  the  ethical  treatment  of  our  fellow  man  in 
the  attainment  and  use  of  technology. 

The  practices  of  medicine  is  both  an  art  and  a  science,  and  we  are 
constantly  seeking  new  means  to  improve  the  quality  and  length  of 


1068 

life.  The  evolution  of  sound  medical  practice  through  the  years  has  re- 
duced the  incidence  of  pain  and  has  done  much  to  advance  the  cause 
of  human  dignity. 

These  procedures,  however,  today  as  always,  require  the  weighing 
of  risk  against  benefit  at  every  level  of  professional  discretion.  It  is 
evident  that  there  is  a  certain  degree  of  risk  attendant  to  any  medical 
procedure. 

Senator  Mondale.  You  heaixi  the  example  of  the  doctor  in  San 
Antonio  and  the  experiment  in  which  mothers  who  went  to  the  hos- 
pital for  help  on  contraception  were  given,  many  of  them,  what  they 
thought  was  a  contraception  pill  but  in  fact  was  not  and  they  became 
pregnant  as  a  result. 

How  do  you  view  that  kind  of  practice  ?  What  do  we  do  about  it  ? 

Dr.  Barclay.  In  the  light  of  guidelines  which  I  have  set  down 
and  will  discuss,  that  experiment  violated  two  important  principles 
of  any  clinical  trial. 

The  first  principle  is :  Is  the  question  being  asked  by  the  trial  suf- 
ficiently important  to  justify  the  use  of  human  subjects  and  submit 
them  to  a  calculated  risk?  That  is  a  matter  of  a  value  judgment. 

Some  person  might  say  that  the  question  of  whether  the  side  effects 
of  the  pill  are  psychological  or  physiological  is  a  very  important 
question. 

On  the  other  hand,  I  am  sure  you  could  find  a  great  many  people 
who  would  disagree  and  say  that  the  answer  to  such  a  question  does 
not  iustify  its  clinical  trial. 

The  second  principle  that  was  violated  in  my  view  is  that  the  sub- 
jects of  this  trial  did  not  give  fully  informed  consent.  They  did  not 
know  what  they  were  being  asked  to  participate  in.  This  is,  they  were 
not  told  that  they  might  receive  a  pill  which  would  not  prevent  preg- 
nancy, and  that  if  they  were  taking  that  pill  there  was  a  very  good 
chance  they  would  become  pregnant. 

If  they  fully  understood  that  and  then  agreed  to  participate  in  the 
trial,  that  would  have  made  the  trial  ethical,  provided  the  first  ques- 
tion was  proper. 

Senator  ^Iondale.  Suppose  the  characterization  we  heard  today  is 
correct.  This  charge  has  been  made  and  not  denied.  The  doctor  gave 
them  a  phony  birth  control  pill. 

Dr.  Barclay.  He  gave  a  placebo,  a  common  practice  in  clinical 
practice. 

Senator  Mondale.  They  were  not  told.  They  came  there  for  con- 
traceptives and  were  given  a  phony  pill  and  got  pregnant.  I  gather 
you  feel  it  is  not  ethical. 

Dr.  IlvRCLAY.  It  is  not  ethical. 

Senator  Moxdale.  What  kind  of  remedies  are  involved  under  exist- 
ing law? 

Dr.  Barclay.  The  common  recourse,  and  probably  the  only  one,  is 
to  sue. 

Senator  Mondale.  Who  should  sue  ?  IMothers  ? 

Dr.  Barclay.  If  you  are  led  to  expect  that  you  are  being  given  a 
medicine  that  you  did  not  receive,  tliat  is  bad  medical  practice. 

Senator  Mondale.  Then  vou  have  to  get  a  doctor  to  testify  in  your 
behalf?  .  ^ 

Dr.  Barclay.  That  is  true. 


1069 

Senator  Mondale  (presiding).  Does  the  medical  professional  have 
Dr.  Barclay.  It  is  not  all  that  difficult.  Many  patients  bring  suit 
in  this  country  and  win  their  suit. 

Senator  Mondale.  (presiding).  Does  the  medical  profession  have 
disciplinary  authority  over  experimentation  ? 

Dr.  Barclay.  Our  disciplinary  procedures  are  limited  by  the  way 

we  are  constituted.  Medical  societies  are  voluntary  organizations. 

You  can  belong  or  not  belong.  As  a  matter  of  fact,  many  physicians 

don't  belong  to  any  medical  society  of  any  kind.  Whether  one  belongs 

to  the  American  Medical  Association  or  not  is  purely  a  voluntary  act. 

We  could  condemn  a  certain  procedure  or  a  certain  experiment  and 

!  bring  the  attention  of  one's  colleagues  and  peers  to  an  unethical  prac- 

j  tice.  But  we  have  no  punitive  measure. 

'      Senator  Mondale.  Has  anything  happened  in  this  case?  What  did 
1  the  profession  do  when  wide  publicity  was  given  to  this  experiment? 
D.  Barclay.  Whether  or  not  the  man  would  be  brought  before 
a  disciplinary  committee  would  be  the  responsibility  of  his  county 
medical  society,  if  he  belonged  to  a  county  medical  society. 
Senator  Mondale.  And  what  would  they  do  ? 
!      Mr.  HoLMAN.  There  was  a  hearing  before  the  Ethics  Committee 
I  of  the  Bexar  County  Medical  Society  in  San  Antonio,  where  the  facts 
presumably  were  reviewed  by  a  committee  of  Dr.  Goldzieher's  peers. 
I  That  committee.  Senator  Mondale,  found  that  he  did  comport  him- 
self in  accord  with  recognized,  established  and  published  ethical  prin- 
ciples. 
Senator  Mondale.  They  cleared  him,  they  said  it  was  okay. 
I      Mr.  HoLMAN.  Yes,  sir.  I  think  in  Dr.  Edwards'  testimony  there 
I  was  some  reference  made  to  a  black  list,  so  to  speak,  of  investigators. 
I  I  don't  know  that  Dr.  Goldzieher's  name  was  ever  given  to  FDA. 
I      I  think  we  have  two  points,  if  I  can  interrupt.  One,  assuming  the 
facts  as  they  w^ere  presented  by  Dr.  Beecher,  we  would  all  agree  that 
they  were  unethical.  How^ever,  the  reports  I  have,  and  the  statement 
from  the  Bexar  County  Medical  Society  Ethics  Committee,  indicate 
that  those  women  were  advised.  Whether  they  were  advised  as  thor- 
oughly as  you  or  I,  lawyers,  would  advise  them,  is  another  matter.  But 
according  to  the  doctors  who  reviewed  the  facts,  those  women  were 
advised. 
Senator  Mondale.  Then  what  w^as  the  experiment  ? 
Mr.  HolMan.  The  experiment  was  what  Dr.  Beecher  set  out. 
Senator  Mondale.  As  I  understand  it,  the  trick  was  to  find  out 
whether  taking  the  pill  w^as  physiological  or  psychological.  So  they 
were  going  to  find  out  by  not  telling  the  mother,  to  see  which  it  was. 
If  they  told  her,  what  did  they  learn  ?  Why  would  they  come  to  get 
contraception  and  then  be  told,  "This  is  not  a  contraceptive." 

Mr.  HoLMAN.  They  were  told  to  continue  using  whatever  form  of 
contraceptive  practice  they  had  been  using  up  to  that  point.  They  were 
told  this  was  a  double  blind  experiment. 

Senator  Mondale.  What  do  you  mean  by  double  blind  ? 
Dr.  Barclay.  Neither  the  investigator  nor  the  patient  knows  what 
i  the  medicine  is  that  is  being  administered. 
I      Senator  Mondale.  Neither  the  patient  nor  the  investigator? 

Dr.  Barclay.  It  is  double  blind.  Both  sides  of  the  experiment  are 
blind  to  the  procedure. 


1070 

Senator  Mondale.  Was  this  a  contraceptive  clinic  ? 

Mr.  HoLMAN.  No,  sir;  it  was  not. 

Senator  Mondale.  I  think  we  ought  to  inquire  of  the  medical  so- 
ciety for  a  report.  Maybe  we  can  get  a  copy  of  the  consent  form.  But 
on  its  face,  as  it  was  described,  it  seemed  like  an  outrage.  Maybe  we 
don't  understand  it. 

Mr.  HoLMAx.  The  idea  of  the  experiment  is  revolting  to  all  of  us, 
I  am  sure.  But  what  was  done  in  that  particular  set  of  circumstances 
may  comply  with  established  procedures.  That  is  the  only  point  I 
am  trying  to  make.  We  all  disagree  heartily  with  the  lack  of  informed 
consent,  the  abuse,  particularly  when  there  is  a  language  barrier.  That 
is  possible. 

Dr.  Barclay.  But  if  we  are  to  continue  to  improve  our  high  stand- 
ards of  patient  care,  we  must  maintain  our  initiatives  in  biomedical 
research.  The  accomplishments  of  modern  medical  practice  testify  to 
the  merits  of  continued  research.  Such  advances  are  hard  won,  but 
the  benefits  are  beyond  question. 

Medicine  as  a  science  must  conduct  experimentation  if  it  is  to  pro- 
gress rather  than  stagnate.  Experimentation  is  an  essential  principle 
of  all  sciences,  be  they  biological  or  physical.  Scientific  experiments 
are  conducted  both  to  test  new  hypotheses  and  also  to  reexamine  the 
validity  of  accepted  hypotheses. 

A  medical  experiment"  with  human  subjects  is  sometimes  referred 
to  as  a  clinical  trial.  As  such  it  should  be  a  test  of  a  reasonable  hypoth- 
esis based  on  sound  laboratory  data.  It  should  not  be  a  random 
groping  for  information. 

A  well  designed  clinical  trial  has  elements  in  its  design  which 
assure  that.it  will  be  a  useful  and  justifiable  undertaking.  The  essen- 
tial features  of  a  sound  experimental  design  fall  into  two  categories : 
scientific  and  ethical. 

1.  A  "control  group''  must  be  established  against  which  one  can 
compare  the  treatment  group.  Persons  placed  in  the  control  group 
must  be  comparable  in  as  many  respects  as  possible  to  those  receiving 
the  experimental  treatment. 

2.  Scientific  numbers  of  people  must  be  enrolled  in  the  control  and 
the  treatment  group  to  make  any  differences  in  outcomes  statistically 
meaningful.  However,  unnecessary  numbers  of  subjex:ts  should  not 
be  used  so  that  any  undesirable  effects  of  the  experiments  are  mini- 
mized. 

3.  The  effects  anticipated  from  the  experimental  procedure  must  be 
measurable  and  if  possible  quantifiable. 

4.  The  results  of  the  experiment  should  be  published  as  quickly  as 
possible  and  made  widely  available  to  the  medical  community.  This 
not  only  assures  an  exchange  of  information  among  researchers  and 
prompt  transmission  of  such  information  to  practitioners,  but  also 
prevents  redundant  and  possibly  hazardous  testing. 

5.  Participants  in  any  human  experiment  must  give  informed  con- 
sent. The  purpose  of  the  experiment,  the  potential  benefits,  the  po- 
potential  risks,  the  safeguards  being  employed  should  be  revealed. 
Because  of  complex  technical  factors  involved,  many  persons  will  rely 
on  the  integrity  and  knowledge  of  the  physician  who  recommends 
their  participation.  This  dependency  of  the  patient  on  his  physician  is 
a  sacred  trust  and  must  not  be  abused  or  exploited. 


1071 

6.  Adequate  safeguards  must  be  built  into  the  design  of  the  experi- 
ment to  assure  regular  and  frequent 'review  of  its  progress  by  indi- 
viduals not  directly  conducting  the  experiment. 

Keeping  the  above  principles  of  clinical  trials  in  mind,  we  can  now 
confront  the  difficult  central  issue  which  underlies  all  human  experi- 
ments. A  human  experiment,  by  its  very  nature,  establishes  a  set  of 
circumstances  which  will  place  some  of  the  participants  at  a  calculated 
disadvantage.  Generally  a  trial  is  established  to  answer  the  question, 
"Is  treatment  A  better  than  treatment  B?"  No  definitive  answer  to 
this  question  can  be  obtained  until  the  test  is  conduced  over  an  ade- 
quate period  of  time  and  sufficient  data  has  been  gathered  by  which  to 
measure  the  relative  response  of  the  subjects. 

When  that  has  occurred,  of  course,  one  realizes  that  the  subjects 
in  treatment  A  or  treatment  B  have  been  disadvantaged. 

Through  the  process  of  clinical  investigation,  which  we  have  de- 
scribed here,  drugs  and  procedures  become  available  for  widespread 
usage  in  patient  care.  The  question  has  been  raised,  however,  as  to  the 
discretion  vested  in  the  prescribing  physician  once  the  pharmaceutical 
product  has  been  approved  by  the  Food  and  Drug  Administration. 

In  the  course  of  these  hearings  testimony  has  been  given  on  the 
package  insert,  the  regulatory  powers  of  the  FDA,  the  physician's 
privilege  to  prescribe  and  whether  departure  from  the  package  insert 
constitutes  a  medical  experiment. 

Under  the  statute  a  new  drug  cannot  be  marketed  until  it  has  been 
approved  by  FDA.  Approval  is  granted  on  the  basis  of  satisfying 
requirements  for  demonstrating  tne  safety  and  effectiveness  of  the 
drug  for  a  stated  use;  and  the  approved  use  must  be  shown  on  the 
drug  label. 

While  the  law  specifies  the  conditions  under  which  a  manufacturer 
may  introduce  a  new  drug  into  interstate  commerce,  it  does  not  con- 
trol the  uses  a  physician  may  make  of  substances  categorized  as  drugs, 
after  it  has  entered  interstate  commerce. 

Clearly,  Congress  did  not  intend  that  the  FDA  regulate  or  interfere 
with  the  practice  of  medicine,  and  this  has  been  specifically  acknowl- 
edged by  FDA. 

The  package  insert  is  a  document  which  limits  the  claims  that  a 
manufacturer  may  make  for  the  product  and  outlines  the  conditions 
for  which  the  product  can  be  shipped  in  interstate  commerce.  The 
information  given  in  the  insert  is  relatively  incomplete,  chosen  with 
safety  uppermost  and  is  extremely  useful  in  a  limited  sense.  It  is 
regulatory  in  nature;  it  is  not  a  scientific  document.  By  its  nature 
and  purpose  it  has  certain  shortcomings. 

For  example,  it  lists  all  known  adverse  reactions  but  does  not 
weigh  the  frequency  of  their  occurrence.  A  reaction  which  occurs  in 
one  in  a  million  patients  appears  in  the  same  list  as  one  occurring  one 
in  a  thousand. 

Furthermore,  risks  must  always  be  judged  in  relationship  to  the 
benefit  in  each  individual  patient.  The  insert  serves  as  a  warning  or 
a  reminder  but  it  cannot  be  the  final  guide  to  prescribing. 

Moreover,  the  doses  listed  in  the  insert  are  average  doses  and,  while 
they  do  apply  to  most  patients,  patients  differ  widely  in  their  need  for 
and  their  response  to  a  given  drug.  If  the  dose  schedule  in  the  package 


1072 

insert  allowed  too  great  a  latitude  the  document  would  lose  its  in- 
tended warning  character. 

By  the  same  token,  if  physicians  are  forced  to  prescribe  only  within 
the  dosage  range  published  in  the  insert,  some  patients  would  be 
seriously  harmed. 

Approval  by  the  FDA  of  a  new  drug  application,  or  marketing  ap- 
proval, is  not  and  should  not  be  considered  conclusive  evidence  of  either 
safety  or  efficacy. 

FDA  approval  simply  means  that  there  has  been  a  sufficient  num- 
ber of  clinical  trials  to  warrant  making  the  "new  drug"  available  for 
use  by  all  physicians.  Thus,  the  broad  experience  of  expanded  use  be- 
comes the  important  consideration  for  the  prescribing  physician.  The 
prescribing  pliysician  is  the  best  person  to  judge  what  is  needed  for  his 
patient. 

Let  me  cite  a  few  instances  where  patients  would  have  been  denied 
beneficial,  and  in  some  cases  lifesaving  therapy  if  the  use  of  the  drug 
were  limited  only  to  labeled  uses.  Lidocaine  Hydrochloride  was  in- 
troduced and  is  still  used  as  a  local  anesthetic. 

For  many  years,  however,  this  drug  had  widespread  recognized 
use  as  an  antiarrhythmic  agent  prior  to  formal  recognition  in  labeling. 
It  is  now  accepted,  but  in  that  interim  many  lives  were  saved  by 
doctors  making  use  of  the  drug. 

Propranolol  Hydrochloride,  labeled  for  treating  various  cardiac 
arrythmias,  subaortic  stenosis,  and  pheochromocytoma,  is  also  used 
effectively  for  treatment  of  hypertension  and  angina  pectoris  in  some 
patients.  Other  clinical  uses  include  treatment  of  chronic  alcoholics 
and  persons  addicted  to  heroin. 

Diphenylhydantoin  is  an  anticonvulsant  drug  used  to  treat  epilepsy. 
It  has  subsequently  been  found  to  be  a  useful  agent  in  treating  certain 
cardiac  arrhythmias.  It  may  well  be  the  drug  of  choice  for  treating 
toxic  arrhythmias  caused  by  digitalis  overdosage. 

These  examples  do  not  reflect  adversely  upon  the  Food  and  Drug 
Administration.  They  simply  demonstrate  that  the  FDA  regulatory 
process  cannot  be  expected  to  represent  the  sum  total  of  scientific 
thought.  The  FDA  was  never  expected  to  perform  such  a  function, 
and  no  public  or  private  agency,  no  matter  how  prestigious,  can  be 
expected  to  become  the  sole  repository  of  scientific  truth. 

Individual  responsibility  must  continue  to  be  the  foundation  upon 
which  the  physician-patient  relationship  rests. 

We  note  from  the  opening  statement  of  the  chairman,  that  it  is  the 
committee's  hope  that  these  hearings  will  encourage  continued  support 
of  and  advancement  of  biomedical  research.  If  we  are  to  continue  to 
increase  our  knowledge  and  continue  to  improve  medical  care  for  the 
benefit  of  society,  medical  research  using  human  subjects  is  essential. 

Senator  Mondale.  Thank  you  very  much.  Dr.  Barclay. 

Senator  Kennedy,  the  chairman,  had  to  leave  for  a  meeting  with  the 
Judiciary  Committee.  He  will  return  in  a  few  minutes.  If  you  would, 
wait  for  just  a  few  minutes  and  Senator  Kennedy  will  be  back. 

We  will  stand  in  recess  until  that  point  in  time. 

(Brief  recess.) 

Senator  Kennedy.  The  subcommittee  will  be  in  order. 

Di".  Barclay,  many  thanks  for  your  patience  and  indulgence.  As  so 
often  happens,  I  have  been  caught  between  two  different  committee 


i 


1073 

meetings.  They  are  just  winding  up  on  Mr.  Gray  downstairs.  I  am  a 
member  of  the  Judiciary  Committee  and  had  to  return.  I  want  to  thank 
you  very  much  for  your  being  with  us. 

You  are  our  final  witness  in  this  series  of  hearings  that  we  have 
held  over  the  period  of  the  last  six  days,  spanning  some  two  w^eeks. 
We  have  heard  about  some  enormously  distressing,  depressing  and 
truly  outrageous  situations  that  cover  a  wide  gamut  of  different 
concerns. 

Did  you  have  a  chance  at  all,  prior  to  coming  up  here,  to  familiarize 
yourselves  with  some  of  the  problems  that  were  suggested  in  our  hear- 
ings related  to  the  use  of  experimental  drugs  being  used  on  the  basis 
of  an  independent  physician's  judgment  without  the  kind  of  careful 
review  or  control  or  reporting  by  any  kind  of  a  peer  group  or  clinical 
setting  or  without  any  kind  of  real,  essential  follow-up  ? 

We  heard  this  in  the  cases  in  regard  to  diethylstilbestrol  and  Depo- 
Provera.  So  often  we  hear  today  that  what  the  American  people  do 
not  want  is  big  brother  looking  over  their  shoulder. 

We  don't  want  interference  from  Washington.  We  don't  want  bureaucracy 
from  the  National  Government  to  interfere  in  the  practice  of  medicine.  We  don't 
think  legislators  or  bureaucrats  in  Washington  ought  to  be  telling  us  how  to 
practice. 

But  what  are  we  going  to  say  to  those  thousands  of  people  that  today 
are  receiving  drugs,  experimental  drugs,  that  have  never  been  ap- 
proved for  that  purpose,  who  are  receiving  those  drugs  on  the  basis 
of  an  individual  physician's  judgment,  without  any  kind  of  peer  re- 
view, without  any  kind  of  a  follow-up,  when  there  is  very  significant 
evidence  that  those  drugs  in  some  cases  have  been  cancer-producing 
with  some  individuals  ? 

What  is  organized  medicine  doing  to  help  us  meet  this  quality  is- 
sue ?  What  kind  of  leadership  are  they  willing  to  provide  so  that  we 
in  the  Legislative  Branch  can  work  with  them  in  attempting  to  rem- 
edy what  must  be  recognized  by  all  citizens  as  an  enormously  dan- 
gerous situation. 

Dr.  Barclay.  I  think  one  has  to  differentiate  between  a  medical  ex- 
periment which  asks  a  question  and  you  define  rather  rigidly  how 
you  are  going  to  answer  it,  and  you  involve  a  great  many  people  in 
the  trial  which  answers  the  question,  and  you  do  it  for  the  general 
social  good. 

You  must  differentiate  that  from  administering  a  drug  to  a  patient 
on  a  one-to-one  basis,  physician  and  patient,  for  a  certain  complaint  or 
condition. 

One  could  not  condone  the  capricious,  ill-advised  prescribing  of  a 
drug,  and  the  physician  should  be  brought  to  task  for  that  in  a  court 
of  law. 

Senator  Kennedy.  By  who  ?  Who  should  they  be  brought  to  a  court 
of  law^  by  ? 

Dr.  Barclay.  If  one  is  capricious  and  ill-advised,  damaging  effects 
occur.  However,  what  is  known  scientifically  about  pharmacology  is 
not  entirely  contained  within  the  FDA  package  insert.  With  respect  to 
diethylstilbestrol,  for  example- 

Senator  Kennedy.  Let  me  interrupt  you  there.  You  are  not  trying 
to  possibly  suggest  now  that  the  independent  physician  ought  to  be 
able  to  prescribe  drugs  which  have  been  approved  for  one  purpose, 
for  another  purpose,  are  you  ? 


1074 

Dr.  Barclay.  Yes. 

Senator  Kennedy.  You  are  ? 

Dr.  Barclay.  Yes. 

Senator  Kennedy.  Without  any  kind  of  formal  review  or  follow- 
up^ 

Dr.  Barclay.  There  is  a  formal  review  because  of  the  published 
literature  not  only  from  the  United  States  but  most  other  countries 
around  the  world,  courses  given  at  medical  meetings  in  which  the 
use  of  a  drug  is  advocated,  which  may  not  be  in  the  package  insert— — 

Senator  Kennedy.  Is  there  any  requirement  that  doctors  are  going 
to  read  published  literature?  We  produce  the  Congressional  Record 
every  day  and  I  don't  think  out  of  100  Members  of  the  Senate  half  of 
them  read  it  cover  to  cover. 

Is  there  a  requirement  that  doctors  read  material  and  a  requirement 
to  take  courses  ? 

Dr.  Barclay.  There  is  a  requirement  for  certain  awards,  yes.  One 
must  demonstrate  competence  by  examination  to  belong  to  certain 
scientific  societies.  You  are  tested  on  your  knowledge  of  medical  litera- 
ture. You  are  tested  for  your  competence  before  you  belong  to  the 
American  College  of  Physicians,  for  example.  AMA  has  a  Physician's 
Recognition  Award  in  which  we  try  to  promote  continuing  medical 
education.  But  the  sum  total  of  use  and  knowledge  about  a  drug  is 
simply  not  contained  in  the  package  insert.  It  never  could  be.  Other- 
wise, the  value  of  the  insert  would  be  lost. 

A  doctor  does  not  capriciously  select  a  drug  and  say,  "I  am  going 
to  try  this  for  a  condition."  He  tries  a  drug  and  uses  a  drug  on  an 
individual  patient  because  a  body  of  scientific  evidence  produced  by 
reputable  people  and  published  in  the  literature  says  this  is  a  useful 
drug  for  this  condition.  It  may  have  a  certain  risk  to  it.  The  doctor 
weighs  that  risk  and  he  weighs  the  benefit  for  that  patient. 

Sir,  if  you  were  the  physician 

Senator  Kennedy.  Doctor,  on  this  point,  as  far  as  we  heard,  it  doesn't 
apply  to  Depo-Provera  and  didn't  apply  to  DES.  DES  use  was  wide- 
spread in  the  university  medical  complex. 

Dr.  Barclay.  I  am  not  condoning  the  widespread  employment  of 
drugs  with  many,  many  patients.  I  am  saying  that  an  individual 
physician  for  an  individual  patient  has  to  have  a  certain  latitude  of 
discretion  if  he  is  to  exercise  his  art  and  science. 

Senator  Kennedy.  Even  though  to  a  degree,  does  that  include  the 
lability  to  prescribe  drugs  that  have  not  been  approved  for  those 
purposes  ? 

Dr.  Barclay.  But  they  have  been  approved.  It  is  in  the  medical 
literature.  The  FDA  has  not  recognized  it. 

Senator  Kennedy.  But  not  for  those  purposes.  You  understand 
that. 

Dr.  Barclay.  It  has  been  proved  for  those  pur7:>oses  in  the  medical 
literature.  The  medical  literature  clearly  states  that  the  drug  works. 

Senator  Kennedy.  If  it  hasn't  been  approved  by  the  Food  and  Drug 
Administration,  what  knowledge  do  individual  doctors  have  that  the 
Food  and  Drug  Administration  does  not  have  ?  They  don't  find  it  is 
satisfactory  to  meet  their  requirements  and  don't  approve  it,  and  yet 
you  are  suggesting  that  individual  doctors  ought  to  be  able  to  distrib- 
ute or  use  these  various  drugs  because  maybe  they  are  reading  various 
magazines  or  they  are  required  to  take  certain  Boards  or  w^hatever. 


1075 

I  know  as  far  as  a  lawyer,  when  I  passed  that  Massachusetts  Bar,  I 

can  practice  any  time  as  long  as  I  live,  unless  some  other  kind  of  law  is 

I   passed.  I  don't  believe  that  is  different  from  the  medical  profession. 

When  you  pass  it  in  1923  you  can  practice  in  1973,  if  you  are  still 
able  to  do  so. 

Dr.  Barclay.  Could  I  pose  a  situation  to  you,  Senator  Kennedy  ?  The 
drug  diphenlyhydantoin  is  approved  by  the  FDA.  It  is  a  very  common 
drug.  You  can  secure  it  in  any  pharmacy.  It  has  an  approved  use  for 
the  treatment  of  epilepsy.  From  journals  on  anesthesiology,  pharma- 
cology and  medicine,  every  physician  knows  this  drug  is  probably  the 
drug  of  choice  to  treat  a  cardiac  arrh3i:hmias,  particularly  one  that 
occurs  in  the  operating  room. 

When  an  anesthesiologist  is  confronted  with  a  cardiac  arrhythmias 
and  sitting  next  to  the  table  is  that  drug,  should  the  doctor  say,  "No, 
the  FDA  has  not  approved  this.  I  will  not  use  it.  I  will  let  the  patient 
die"? 

This  is  a  decision  you  can't  make. 

Senator  Kennedy.  I  hope  you  are  not  trying  to  equate  the  use  of  a 
drug  in  an  emergency  situation  in  the  university  center  with  the  ability 
of  an  individual  practitioner  to  distribute  experimental  drugs  in 
Hoboken.  I  hope  that  is  not  the  best  example  you  can  find. 

Dr.  Barclay.  I  can  find  another  example,  rather  a  facetious  one ;  I 
hesitate  to  use  it  but  I  will.  The  Food  and  Drug  Administration  con- 
sidered soft  contact  lenses  to  be  a  drug  and  not  a  device.  Under  the 
Food  and  Drug  Administration,  you  are  recommended  not  to  use  a 
drug  in  the  first  3  months  of  pregnancy.  Therefore,  if  any  doctor  lets 
a  patient  wear  contact  lenses  during  the  first  3  months  of  pregnancy, 
he  is  violating  the  principles  of  the  Food  and  Drug  Administration  set 
forth  in  their  package  insert. 

Senator  Kennedy.  It  is  rather  surprising  to  me  that  you  would  use 
a  legal  technicality  and  the  emergency  situation  of  life  and  death  in  a 
university,'  that  you  would  give  those  as  examples  to  support  your 
thesis  that  an  individual  doctor  in  the  countryside  should  be  able  to 
use  experimental  drugs  when  they  have  never  been  approved. 

I  think  it  makes  the  case,  quite  frankly,  Doctor.  I  think  it  makes  the 
point,  if  those  are  the  best  examples  you  can  come  up  with. 

Dr.  Barclay.  I  have  been  a  physician  at  one  time  in  my  career  in 
Students  Health  Service.  A  young  coed  came  to  me  and  said  she  had 
been  exposed  to  the  risk  of  pregnancy  the  previous  night  and  if  she 
became  pregnant  it  would  really  destroy  her  career.  She  would  have  to 
leave  college.  She  was  very  distraught  and  upset  about  it. 

If  I  knew  that  by  prescribing  diethylstilbestrol  I  could  assure  her 
she  would  not  become  pregnant  I  would  be  sorely  put  not  to  take  action 
to  help  that  girl. 

Senator  Kennedy.  Tliere  is  no  way  that  you  can  assure  her  that  she 
will  not  get  cancer  ? 

Dr.  Barclay.  There  has  never  been  a  recorded  case  of  cancer  from 
this  drug  when  it  has  been  given  to  a  person  beyond  the  fetal  stage 
of  life. 

Senator  Kennedy.  The  evidence  is  that  the  Food  and  Drug  Adminis- 
tration, with  all  of  their  resources,  all  of  their  techniques,  that  they 
refuse  to  approve  it  for  that  purpose,  and  Dr.  Edwards  indicated  he 
would  be  alarmed  if  use  was  widespread.  You  feel  as  an  individual  that 
you  can  use  it. 


1076 

Dr.  Barclay.  One  weighs  the  risks  against  the  benefits.  I  think  the 
benefits  in  this  case  outweigh  the  risk  of  cancer. 

Senator  Kennedy.  Your  position  is  that  any  doctor  ought  to  be 
permitted  to  make  that  judgment? 

1  )r.  Barclay.  I  don't  see  how  you  can  at  this  point  in  our  medical 
structure  separate  doctors  out  for  competence  eitner  to  do  this  or  not 
to  do  it.  We  have  only  one  class  of  drugs. 

Senator  Kennedy.  We  hear  in  San  Joaquin,  the  Foundation,  they  do 
a  pretty  good  job.  That  is  run  by  various  medical  groups,  over  100 
doctors. 

Dr.  Barclay.  You  can  do  it  in  your  own  group  practice. 

Senator  Kennedy.  They  said  you  could  do  it  nationally. 

Dr.  Barclay.  We  have  only  attempted  to  regulate  prescribing  privil- 
eges nationally  with  respect  to  one  category  of  drugs  and  that  is  ra- 
dioactive drugs.  This  is  unique.  That  is,  we  took  drugs  with  a  very 
special  hazard  and  we  have  allowed  only  certain  physicians  with  spe- 
cial qualifications  to  prescribe  them.  That  is  one  example  of  limited  use. 

However,  the  physician  also  is  in  a  peculiar  position  with  respect  to 
the  general  attitude  of  society  toward  drugs. 

The  one  drug  that  medical  science  has  proven  without  any  doubt  in 
human  beings  causes  cancer,  and  we  can  statistically  state  the  chances 
of  getting  cancer,  the  most  incurable  cancer  in  man,  the  commonest 
cancer,  is  tobacco.  And  yet  members  of  our  society  knowing  this  decide 
that  benefits  of  using  this  drug  outweigh  the  risks  personally,  and  you 
feel  free  to  indulge.  I  believe  that  is  your  privilege. 

If  one  says  to  a  coed,  "Tliere  is  a  very  remote  chance  you  will  have 
cancer  and  there  is  a  very  good  chance  that  vou  will  not  become  preg- 
nant if  I  use  this  drug,"  I  believe  she  has  tne  right  to  make  her  own 
decision  and  say,  "Doctor,  I  want  the  drug." 

Senator  Kennedy.  And  what  about  psychosurgery?  Do  you  think 
the  same  ought  to  be  true  about  that  ? 

Di'.  Barclay.  I  would  have  to  decline,  sir.  I  am  not  an  expert  in 
neurology  or  in  this  area  of  medicine.  I  am  not  really  conversant 
with  the  literature  on  psychosurgery. 

Senator  Kennedy.  What  about  the  general  thesis  of  the  surgeons, 
of  freedom  to  use  experimental  surgery  ?  What  does  organized  medi- 
cine say  about  that  ? 

Dr.  Barclay.  We  have  improved  the  methods  of  review.  I  have 
been  a  participant  in  a  team  that  did  experimental  surgery  along  with 
experimental  drugs.  I  believe  that  the  experiment  should  be  very 
strictly  controlled. 

By  the  way,  I  support  what  has  been  stated  here  earlier.  We  should 
have  a  national  commission  of  some  sort  that  reviews  and  issues  guide- 
lines and  monitors,  and  keeps  the  subject  constantly  before  us. 

I  think  when  these  committee  hearings  end,  the  importance  of  this 
subject  should  not  drop  from  the  public  or  professional  attention. 
The  thing  that  will  make  a  real  difference  is  what  you  can  do  locally. 
It  is  all  very  well  to  have  a  national  body,  but  what  do  you  do  about 
that  local  hospital,  university  or  clinic?  Universities  have  established 
committees  on  human  experimentation. 

The  committee  members  must  not  be  a  part  of  the  experimental 
team.  They  must  have  no  vested  interest  in  the  experiment.  They 
must  make  an  impartial  judgment.  As  with  my  Veterans  Adminis- 


'.•       1077  I  i 

tration  Committee,  that  committee  should  review  constantly  the  course 
of  the  experiment  so  that  if  any  undue  harm  is  coming  to  any  member 
who  participates  in  that  experiment,  the  experiment  will  be  either 
changed  or  halted. 

Senator  Kennedy.  What  is  the  AMA  doing  as  far  as  the  local 
kind  of  review  ?  You  say  it  is  important  that  this  be  developed.  What 
is  the  AMA  doing  to  try  to  achieve  the  kinds  of  suggestions  presented 
here  ? 

Dr.  Barclay.  We  have  encouraged  and  actually  participated  in 
continuing  medical  education,  to  bring  this  subject  constantly  before 
the  medical  profession.  We  can  use  strict  criteria  on  the  acceptance 
of  articles  in  our  journals  to  be  sure  that  no  experiment  published 
receives  credit  unless  proper  prior  review  and  monitoring  is  done 
of  the  experiment. 

As  the  umbrella  organization,  we  are  a  federation.  People,  I  think, 
have  a  misunderstanding  about  what  the  AMA  is.  We  are  really  a 
central  body  under  which  all  medical  societies^  State  and  special  so- 
cieties, can  come  and  wrestle  with  these  very  serious  problems,  whether 
scientific,  technical,  moral  or  economic. 

We  can  encourage  specialty  societies  to  come  before  us  and  to  pro- 
duce this  kind  of  document  in  my  hand. 

We  also  can  recommend  in  our  accreditation  of  medical  schools  that 
this  subject  receive  prominent  attention  in  the  curriculum. 

We  can  recommend  to  State  licensing  boards  that  this  be  a  part  of 
the  licensing  of  a  physician,  that  before  he  receives  a  license  he  dem- 
onstrates his  awareness  of  the  problem  and  his  obligations  under  that 
awareness. 

These  are  the  sorts  of  things  we  can  do.  We  have  not  always  done 
them  well.  Lwill  say  that,  sir. 

Senator  Kennedy.  Do  you  think  that  the  AMA  has  a  position  that 
DES  should  be  permitted  to  be  used  in  the  university  complexes  around 
the  country? 

Dr.  Barclay.  We  would  not  enter  into  that  controversy.  Our  re- 
sponsibility ends  with  the  publication  of  a  scientific  article.  We  could 
bring  this  sub j  ect  up. 

Senator  Kennedy.  Whose  responsibility  is  it  ? 

Dr.  Barclay.  It  is  the  individual  physician  treating  an  individual 
patient.  It  is  the  responsibility  of  the  university,  if  it  is  being  used 
widely  as  a  common  procedure  on  large  numbers  of  people. 

Senator  Kennedy.  The  control  is  up  to  the  individual  physician  is 
what  you  are  saying  ? 

Dr.  Barclay.  Yes. 

Senator  Kennedy.  Why  have  FDA,  then,  charged  with  improving 
and  reviewing  various  drugs,  with  all  of  the  kinds  of  procedures  which 
they  have  outlined?  Is  it  your  position  that  a  doctor  ought  to  be  able 
to  exercise  an  independent  judgment  of  what  he  thinks  best  to  pre- 
scribe as  a  drug,  even  though  it  has  not  been  approved  by  the  Food 
and  Drug  Administration,  and  even  when  the  head  of  the  Food  and 
Drug  Administration  after  years  of  study  indicated  his  very  grave 
alarm  at  a  general  use  of  this  type  of  drug  ? 

Dr.  Barclay.  The  Food  and  Drug  Administration  has  limited  staff. 
Because  they  must  exercise  extreme  caution,  safety  is  paramount.  They 
will  often  act  late.  The  Food  and  Drug  Administration  cannot  pos- 


93-999  O  -  73  -pt.  3  —  19 


1078 

sibly  have  the  same  mass  of  scientific  experience  within  it  that  exists 
outside  of  it,  in  the  rest  of  the  world. 

Senator  Kennedy.  Do  you  think  an  individual  doctor  has  more 
than  the  accumulated  Food  and  Drug  Administration? 

Dr.  Barclay.  He  may  very  well  have.  I  know  a  great  many  physi- 
cians who  are  much  more  conversant  with  drugs  than  anyone  in  the 
Food  and  Drug  Administration. 

The  FDA  has  good,  common,  dedicated  people,  but  not  the  best  sci- 
entists in  the  country. 

Senator  Kennedy.  Is  the  individual  doctor  out  in  the  Midwest  or 
Far  West  or  even  in  the  smaller  communities  in  Massachusetts  better 
able  and  equipped  to  make  these  judgments  than  they  are  in  the  Food 
and  Drug  Administration  ? 

Dr.  Barclay.  To  make  a  judgment  on  the  recommendation  of 
people  he  respects.  He  may  respect  the  body  of  scientific  opinion 
published  in  the  medical  literature  more  than  he  respects  the  Food 
and  Drug  Administration. 

Senator  Kennedy.  Then  who  is  to  protect  the  consumer  ?  Why  don't 
you  come  up  and  say  what  the  Food  and  Drug  Administration  needs 
are  topflight  scientists  ?  "If  you  do  that,  Senator,  you  can  get  the  best 
there  are ;  if  you  are  willing  to  pay  them,"  willing  to  provide  the  kind 
of  resources  that  will  give  them  the  tools  to  be  the  best." 

Why  don't  you  say  that  and  then  have  one  place  in  this  country 
where  we  know  we  will  be  able  to  get  the  best.  Your  testimony  is  be- 
cause they  are  overworked,  overstressed  and  really  not  quite  as  good  as 
they  may  be  outside,  that,  therefore,  the  individual  doctor  in  the 
small  communities  of  Massachusetts  or  out  West  ought  to  be  able 
to  exercise  that  judgment. 

Dr.  Barclay.  I  think  they  do  resort  to  outside  consultation,  but  the 
trouble  with  ^oing  into  the  Food  and  Drug  Administration  if  you  are 
a  topflight  scientist  is  you  wouldn't  remain  so,  because  to  be  a  top- 
flight scientist  means  continuous  work  and  experimentation  in  the 
field. 

You  can't  remain  a  topflight  lawyer  if  you  are  a  full-time  Senator, 
for  example.  You  just  don't  have  the  time  and  capacity  to  stay  an 
expe-rt  in  both  politics  and  law.  You  can  be  good  but  not  an  expert. 

Senator  Kennedy.  There  are  some  good  Senators  and  not  so  good 
Senators.  I  am  sure  that  is  probably  true  about  your  profession. 

Dr.  Barclay.  I  am  sure. 

Senator  Kennedy.  But  should  the  not-so-good  doctors  be  able  to 
prescribe  the  medicines  that  they  independently  deem  to  be  advisable 
even  though  the  Food  and  Drug  Administration  says  they  are  not 
safe  for  this  kind  of  use?  That  is  your  testimony. 

Dr.  Barclay.  I  believe  that  the  misuse  of  drugs  is  not  so  great  that 
it  warrants  putting  an  absolute  ban  on  a  doctor's  privilege  to  prescribe. 

To  legislate  that  the  doctor  could  not  use  a  drug  in  any  way  except 
that  in  the  package  insert.  Commissioner  Edwards  himself  has  testi- 
fied, would  hurt  medicine. 

Sejiator  Kennedy.  How  many  deaths  do  we  have  from  adverse  drug 
reactions  ? 

Dr.  Barclay.  I  don't  think  anybody  really  knows. 

Senator  Kennedy.  The  best  estimate  from  HEW  was  in  excess 
of  30,000. 


I 


1079 

Dr.  Barclay.  But  that  is  an  estimate.  1  don't  think  anybody  really 
knows. 

Senator  Kennedy.  The  best  estimate  of  HEW  is  that  it  is  in  excess 
of  $2  billion  a  year  in  costs. 

Dr.  Barclay.  Not  all  of  those  deaths  were  preventable,  sir. 

Senator  Kennedy.  What  is  the  AMA  doing  to  try  to  get  us  that 
kind  of  information?  You  say  you  don't  know.  All  we  have  to  go 
on  is  the  material  made  available  to  us  from  HEW.  What  are  we 
supposed  to  do? 

Dr.  Barclay.  We  looked  into  trying  to  get  this  kind  of  data  in  co- 
operation with  the  Food  and  Drug  Administration,  and  Dr.  Boston 
with  his  computer  review  of  drug  interactions,  and  we  found  the  costs 
exceeded  that  which  we  were  able  to  meet. 

Senator  Kennedy.  You  used  to  have  a  Council  of  Drugs.  What 
happened  to  that  ? 

Dr.  Barclay.  The  Council  on  Drugs  was  abandoned  or  discharged 
by  the  Board  of  Trustees.  That  Council  was  a  very  important  council 
through  much  of  AMA's  history.  At  one  time,  before  the  FDA  became 
active,  the  AMA  used  to  test  drugs  for  safety,  biovailability,  and  our 
Council  had  an  active  clinical  testmg  laboratory  in  the  AMA  building. 

When  the  FDA  took  on  this  responsibility,  as  it  should  have,  the 
AMA  dropped  it.  Also,  AMA  had  a  seal  of  approval  policy  for  its 
journals.  That  is,  we  would  not  accept  advertising  unless  it  met 
the  strict  scientific  criteria  for  the  drug  set  by  the  Council  on  Drugs. 

When  the  FDA,  with  the  Harris-Kefauver  Amendments,  incor- 
porated efficacy  into  the  package  insert  as  well  as  safety,  we  felt  we  no 
longer  had  a  role,  since  all  advertising  was  strictly  regulated  by  the 
government. 

We  did  not  feel  we  should  add  another  review  of  that.  So  the  Coun- 
cil on  Drug's  responsibility  was  reduced  to  writing  a  book  on  Drug 
Efficacy,  a  critical  appraisal  of  drugs,  their  use,  and  their  adverse 
effects.  When  they  had  completed  the  second  edition,  they  had  no 
other  mission. 

They  were  not  the  only  council  that  was  disbanded.  As  we  looked 
at  the  AMA  in  the  last  two  or  three  years,  it  became  apparent  that 
we  were  not  structured  to  respond  quickly  and  effectively  to  the  very 
serious  questions  that  beset  medicine.  The  Board  of  Trustees  decided 
that  rather  than  have  rigid  councils  where  men  serve  for  10  years j  with 
limited  missions,  that  we  should  put  our  money  into  ad  hoc  committees. 

We  are  not  abandoning  our  interest  in  drugs.  We  are  convening  a 
meeting  on  Monday  of  experts  from  all  over  the  United  States  to  study 
the  question  of  the  abuse  and  misuse  of  antibiotics.  We  have  done  this 
at  the  request  of  Dr.  Edwards. 

We  hope  we  will  be  able  to  suggest  ways  of  getting  at  the  problem 
in  the  abuse  and  misuse  of  antibiotics.  We  nave  a  Committee  on  Hyper- 
tension, looking  at  the  drugs  on  heart  diseases,  another  on  cancer  look- 
ing at  the  problem  of  cancer  drugs. 

So  we  really  didn't  abandon  our  interest  in  drugs.  We  reformulated 
the  bureaucratic  structure  under  which  we  will  attack  the  problems 
that  are  presented  to  us. 

Senator  Kennedy.  Doctor,  we  have  heard  during  the  last  several 
days  that  there  is  no  agency  of  government  that  is  going  to  be  aware 
of  experimental  surgery  being  done  in  this  country,  there  are  no 
procedures  which  are  required  to  follow  up. 


1080 

Do  I  understand  you  to  say  that  there  is  very  little  that  the  AMA 
can  do  to  even  monitor  the  experimental  surgery  that  may  be  taking 
place  in  this  country  and  that  you  are  leaving  that  up  to  the  individual 
doctor  as  well  ? 

Dr.  Barclay.  I  believe  the  constituent  societies  of  AMA  could  do  a 
good  deal.  I  view  the  problem,  sir,  is  how  do  you  monitor  what  is  going 
on  at  the  local  level.  I  don't  think  a  national  body  can  do  it. 

The  national  body  should  issue  guidelines.  I  think  the  people  who 
are  locally  on  the  spot  should  be  charged  with  the  responsbility. 

Senator  Kennedy.  Are  you  recommending  that  ? 

Dr.  Barclay.  In  a  great  many  places  it  is  being  done.  I  will  be 
the  first  to  admit  that  we  do  not  have  satisfactory  coverage  of  this 
situation. 

Senator  Kennedy.  Are  you  doing  anything  about  it  ? 

Dr.  Barclay.  Yes.  We  try  to  bring  before  our  constituent  societies, 
which  include  more  than  the  State  societies,  the  need  for  strict  control 
over  experimentation. 

We  as  a  national  body  have  outlined  the  guidelines. 

Senator  Kennedy.  What  if  they  don't  follow  the  guidelines  ?  What 
happens  ? 

Mr.  HoLMAN.  Senator  Kennedy,  in  addition  to  the  guidelines,  on 
what  does  AMA  do,  we  followed  Dr.  Beecher  today,  and  I  don't  think 
any  of  us  would  doubt  his  qualifications.  I  happen  to  disagree  with  the 
good  doctor.  He  said  that  the  publication  of  his  in  the  journal  in 
1959  was  like  a  bubble  in  the  air.  This  extensive  report  published  in 
the  Journal  of  the  American  Medical  Association  probably  is  the 
genesis  of  this  hearing  today. 

Dr.  Beecher  followed  his  "Experimentation  in  Man"  with  other 
articles  in  the  New  England  Journal.  He  followed  it  with  his  book, 
which  I  hope  every  member  of  the  committee  has. 

AMA  has  cooperated  with  the  Department  of  HEW  in  this  excellent 
guideline. 

Senator  Kennedy.  I  am  not  talking  about  the  publication  of  mate- 
rial. We  are  talking  about  1,600  people  down  in  Tennessee  receiving 
this  drug,  which  was  never  permitted  for  that  particular  use.  We  are 
talking  about  a  best  estimate  of  900  different  psychosurgical  pro- 
cedures being  practiced  in  this  country  and  no  agency  of  government 
and  no  one  within  organized  medicine  having  any  idea  that  this  is 
taking  place. 

What  you  are  coming  up  here  and  saying  is,  "We  hope  they  will 
read  this  little  document  which  will  spell  it  out."  Some  places  they  do 
and  some  places  they  don't.  I  ask  what  are  you  going  to  do  about  it  ? 
I  gather  from  what  you  say  that  you  are  going  to  publish  more  mate- 
rial. What  are  you  going  to  do  about  it  ? 

^Ir.  HoLMAN.  I  think  this  is  a  wonderful  meeting  right  here.  We 
are  reducing  the  chasm  in  communications.  There  are  many  ways  to 
do  it.  This  is  one.  Your  hearings  are  another. 

Senator  Kennedy.  We  all  agreed  that  we  can't  just  let  a  hearing 
end.  It  will  end  in  a  few  minutes.  What  is  the  AMA  going  to  do 
afterwards  ? 

Mr.  HoLMAN.  A  very  fine  example  of  the  cooperation 

Senator  Kennedy.  I  want  to  know  what  we  in  the  Senate  will  do 
but  I  also  want  to  know  what  vou  will  do. 


1081 

Mr.  HoLMAN.  A  fine  study  of  cooperation  is  the  study  in  Alabama, 
the  study,  the  report  and  the  termination  of  unethical  experimen- 
tations in  the  penal  system  in  the  State  of  Alabama.  The  press  heard 
of  these  unethical  practices. 

Senator  Kennedy.  Why  didn't  the  AM  A  hear  about  it  ? 

Mr.  HoLMAN.  The  AMA  is  a  national  organization.  It  can  do  no 
more  and  does  no  more  than  you  do  about  a  traffic  violation  in 
Roxbury. 

Senator  Kennedy.  What  about  the  local  society?  What  are  they? 

Mr.  HoLMAN.  They  have  expelled  physicians,  criticized  physicians, 
clamped  down  on  physicians.  We  have  neglected  completely  the  hos- 
pital staff  which  is  probably  the  greatest  agency  for  the  control  of  a 
physician's  conduct. 

Senator  Kennedy.  How  many  physicians,  for  example,  have  had 
their  licenses  liii^d  by  the  AMA  ? 

Mr.  HoLMAN.  The  AMA  does  not  grant  or  lift  licenses. 

Senator  Kennedy.  How  many  have  been  censored  ? 

Mr.  HoLMAN.  The  AMA  does  not  censor.  That  is  the  responsibility 
of  the  organization  through  which  a  man  enters  organized  medicine. 

Senator  Kennedy.  How^  many  have  been  censored  in  the  country? 

Mr.  HoLMAN.  I  have  no  idea. 

Senator  Kennedy.  Do  you  know  of  any  ? 

Mr.  HoLMAN.  Yes. 

Senator  Kennedy.  How  many  ? 

Mr.  HoLMAN.  The  last  survey  we  conducted  was  several  years  ago. 

Senator  Kennedy.  Several  years  ago  ? 

Mr.  HoLMAN.  Yes.  We  don't  believe  it  is  necessary  to  conduct  these 
studies  on  an  ongoing  basis. 

Senator  Kennedy.  Then  the  people  know  they  don't  have  any 
danger  of  being  censored.  Don't  they  know  that  ? 

Mr.  HoLMAN.  They  know  that  ibhey  lose  their  hospital  privileges. 
We  don't  think  it  is  important  enough — 

Senator  Kennedy.  What  about  those  900  people  being  operated  on  ? 
Don't  you  think  they  might  think  it  is  important  enough,  or  the  people 
in  the  institutions,  the  mentally  retarded  or  mentally  ill  ? 

Mr.  HoLMAN.  I  think  it  is  very  important  that  they  have  an  in- 
formed knowledge  of  what  is  going  on.  If  they  are  informed  and  they 
consent  and  some  good  results  from  it,  I  can't  see  that  that  is  an  un- 
ethical thing. 

Senator  Kennedy.  Who  will  judge  that?  The  independent,  indi- 
vidual physician? 

Mr.  HoLMAN.  Where  have  these  psychosurgical  experimentations 
been  conducted  ? 

Senator  Kennedy.  You  tell  me. 

Mr.  HoLMAN.  The  ones  I  know  about  have  been  conducted  in  gov- 
ernmental institutions. 

Senator  Kennedy.  Well,  now.  Last  week  the  head  of  NIMH,  the 
Director,  Mr.  Brown,  said  absolutely  not. 

Mr.  Holman.  They  are  conducted  in  Vacaville,  California,  in  the 
State  Penitentiary,  San  Quentin. 

Senator  Kennedy.  We  have  had  testimony  of  some  that  have  been 
done  in  prisons.  Most  have  been  outside  of  any  kind  of  climate  or 
atmosphere  of  clinical  research. 


1082 

Mr.  HoLMAN.  As  a  matter  of  fact,  and  I  don't  know  this  for  a  fact, 
it  is  my  understanding  that  the  attention  that  has  been  directed  to 
psychosurgery  came  from  a  physician  who  thought  that  it  was  not 
proper.  It  was  his  effort.  Whether  he  bring-s  a  charge  before  a  county 
medical  society  of  unethical  conduct  or  whether  be  gives  a  paper 
down  in  Houston  at  a  meeting  of  a  speciality  board,  the  fact  remains 
that  he  did  call  to  the  profession's  attention  and  to  the  public's  atten- 
tion what  he  considered  to  be  dangerous  in  psychosurgery. 

Senator  Kennedy.  As  I  understand  it  even  if  your  AMA  Board 
might  not  approve  of  it,  you  might  not  publish  an  article  that  is  writ- 
ten by  someone  that  is  practicing,  but  as  I  understand  that  is  where 
the  end  of  any  kind  of  teeth  is.  You  just  don't  publish  it.  You  don't 
stop  it.  You  just  don't  publish  it. 

Dr.  Barclay.  We  don't  have  the  power  to  stop  it. 

Senator  Kennedy.  You  don't  even  have  the  power  to  set  up  any 
kind  of  review  requirement  to  see  whether  they  ought  to  be  able  to 
continue  ? 

Dr.  Barclay.  We  would  have  the  power  to  recommend  that  that 
be  done  at  the  State  level.  But  we  don't  have  any  punitive  powers 
in  AMA. 

Senator  Kennedy.  Is  it  the  AMA  position  that  you  recommend  to 
the  various  States  that  they  establish  a  control  ? 

Dr.  Barclay.  Here  it  will  be  established.  Also,  you  must  remember 
that  not  all  physicians  belong  to  the  AMA.  About  half  of  the  phy- 
sicians in  the  country  belong.  We  can  take  no  action  against  them 
which  in  any  way  harms  them.  We  can't  exclude  them  from  member- 
ship. There  is  nothing  we  can  do. 

S?nator  Kennedy.  We  have  gathered  from  your  testimony  here  this 
morning  that  in  the  use  of  drugs,  in  psychosurgery — 

Dr.  Barclay.  I  did  not  comment  on  psychosurgery. 

Senator  Kennedy.  Do  you  want  to  make  a  comment  ? 

Dr.  Barclay.  I  cannot.  I  am  not  competent  to  comment  on  psycho- 
surgery. This  is  a  fiel